Executive – R&D Quality GCP QA
Job Details
Company: Sun Pharmaceutical Industries Ltd.
Business Unit: Sun R&D Quality
Job Grade: G12A
Location: Gurugram – Office
Date Posted: August 25, 2026
Function: R&D Quality / GCP QA
Travel: Nil
Experience: 2–3 years in a BA/BE environment, preferably in QA
Role Overview
The Executive – R&D Quality GCP QA will support quality assurance activities associated with Bioavailability/Bioequivalence (BA/BE) studies, GCP/GLP compliance, clinical research processes, and R&D quality systems.
The role involves conducting and supporting audits, reviewing BA/BE study documentation, assessing compliance with applicable regulations and guidelines, supporting CRO/CSP qualification, reviewing quality management system records, and assisting with regulatory inspections and CAPA activities.
The position requires a strong understanding of GCP, GLP, auditing practices, pharmacokinetics, statistical analysis, Good Documentation Practice, and quality management systems.
Key Responsibilities
BA/BE Study Audits
Conduct audits of BA/BE studies.
Perform bioanalytical in-process audits.
Conduct bioanalytical retrospective audits.
Perform pharmacokinetic audits.
Conduct statistical audits.
Identify potential compliance gaps and non-conformances.
Escalate critical quality or compliance issues to QA management.
Quality Assurance Audits
Conduct system-based audits.
Perform facility-based audits.
Conduct process-based audits.
Support implementation and maintenance of quality assurance programs.
Ensure audit activities are performed according to applicable procedures and regulatory requirements.
CRO, CSP and Supplier Audits
Conduct qualification audits of Contract Research Organizations (CROs).
Conduct Contract Service Provider (CSP) qualification and re-qualification audits.
Conduct material supplier qualification and re-qualification audits.
Assess external partners for compliance with applicable quality and regulatory requirements.
Document audit findings and follow up on corrective actions.
Study Document Review
Review BA/BE study documentation to ensure compliance with applicable regulations, guidelines, and Good Documentation Practice (GDP), including:
Study protocols
Bioanalytical method validation documents
Study raw data
Study reports
Supporting bioanalytical documentation
Pharmacokinetic documentation
Statistical analysis documentation
PBPK/PBBM Review
Review Physiologically Based Pharmacokinetic (PBPK) model reports generated by Sun Pharmaceutical Industries Ltd.
Review Physiologically Based Biopharmaceutics (PBBM) model reports.
Assess documentation for scientific, technical, quality, and compliance considerations.
Identify gaps and communicate observations to relevant stakeholders.
SOP and Quality Documentation
Create, review, coordinate, and implement Quality Assurance Standard Operating Procedures (SOPs).
Support development and implementation of global quality documents, including:
Global Quality Standards (GQSs)
Global Standard Operating Procedures (GSOPs)
Review and support creation of operational-level SOPs in collaboration with R&D stakeholders.
Ensure procedures remain aligned with applicable regulatory and quality requirements.
Technical and Instrument Documentation Review
Review relevant technical and quality documentation, including:
SOPs
GSOPs
Analytical Test Procedures (ATPs)
Instrument qualification documents
Design Qualification (DQ)
Installation Qualification (IQ)
Operational Qualification (OQ)
Performance Qualification (PQ)
Quality Management System
Review QMS records and quality events.
Assess documentation associated with:
Deviations
Incidents
Temporary changes
Change controls
Investigations
Corrective and Preventive Actions (CAPA)
Ensure appropriate documentation and quality processes are followed.
Support identification, assessment, and resolution of quality issues.
Audit Reporting
Prepare audit reports within agreed timelines.
Document audit observations and findings accurately.
Identify non-compliance and non-conformance.
Classify and communicate significant findings appropriately.
Immediately escalate critical issues to QA management when required.
Support follow-up activities related to audit findings and CAPA.
Regulatory Inspection Support
Support regulatory inspections in collaboration with R&D stakeholders.
Assist in inspection preparation activities.
Support development and implementation of CAPA for identified gaps.
Collaborate with relevant teams to address regulatory observations.
Support timely resolution of regulatory queries.
Ensure commitments and corrective actions are completed within agreed timelines.
Training
Provide or support training on applicable:
GCP guidelines
GLP guidelines
Regulatory requirements
SOPs
Quality procedures
Good Documentation Practice
Support awareness and compliance training for relevant R&D stakeholders.
Regulatory and Quality Knowledge
The role requires understanding of:
International GCP regulations
GLP regulations
Clinical research processes
BA/BE study requirements
Quality assurance programs
Quality management systems
Good Documentation Practice (GDP)
Audit principles
Pharmacokinetics
Statistical analysis
Regulatory inspection requirements
CAPA
Change control
Deviation and incident management
Educational Qualification
Minimum graduate or postgraduate degree in Basic Sciences.
Relevant scientific disciplines may include areas such as pharmaceutical, biological, chemical, or related sciences.
Required Experience
2–3 years of experience in a BA/BE environment.
QA experience in a BA/BE environment is preferred.
Experience conducting or reviewing BA/BE-related audits is advantageous.
Experience reviewing PBPK/PBBM studies is preferred.
Exposure to GCP/GLP quality programs is preferred.
Technical Competencies
Understanding of international GCP and GLP regulations.
Understanding of clinical research processes.
Knowledge of GCP/GLP quality assurance programs.
Understanding of auditing principles and techniques.
Knowledge of BA/BE study processes.
Basic understanding of pharmacokinetics.
Understanding of statistical analysis and related tools is preferred.
Knowledge of IT and computer systems.
Understanding of quality management systems.
Ability to review scientific and quality documentation.
Behavioral Competencies
Strong drive to achieve results.
Ability to work effectively within a team.
Customer-centric approach.
Good written communication skills.
Good verbal communication skills.
Strong attention to detail.
Ability to identify and escalate quality issues.
Ability to manage activities within defined timelines.
Collaborative approach to cross-functional work.
Key Functional Areas
GCP Quality Assurance
GLP Quality Assurance
BA/BE Studies
Bioanalytical QA
Clinical Research Quality
Quality Audits
CRO/CSP Audits
Supplier Qualification
Pharmacokinetic Audits
Statistical Audits
PBPK
PBBM
SOP Management
QMS
CAPA
Change Control
Deviation Management
Regulatory Inspection Support
Good Documentation Practice
Key Deliverables
The role may be responsible for delivering or supporting:
BA/BE audit reports
Bioanalytical audit reports
Pharmacokinetic audit reports
Statistical audit reports
CRO/CSP qualification audit reports
Supplier qualification audits
Study document reviews
PBPK/PBBM report reviews
SOPs and global quality documents
QMS record reviews
CAPA activities
Regulatory inspection support
Regulatory query responses
Quality and compliance training
Ideal Candidate Profile
The ideal candidate is a QA professional with 2–3 years of experience in a BA/BE environment, preferably with direct exposure to bioanalytical quality assurance and auditing.
The candidate should understand GCP/GLP regulations, clinical research processes, BA/BE studies, audit practices, quality systems, pharmacokinetics, and Good Documentation Practice.
Experience with PBPK/PBBM studies, CRO/CSP audits, QMS records, CAPA, and regulatory inspection support would provide an additional advantage.
Role Expectations
The successful candidate should be capable of supporting quality assurance activities independently within defined responsibilities, identifying compliance gaps, preparing accurate audit documentation, collaborating with R&D stakeholders, and escalating significant quality concerns appropriately.
Strong attention to detail, scientific understanding, communication skills, and a quality-focused mindset are essential for success in this role.
Company Culture
Sun Pharma emphasizes continuous development, ownership, collaboration, innovation, teamwork, accountability, and professional growth. The organization encourages employees to take charge of their careers while contributing to high-quality research and development activities.
Disclaimer
This job description describes the general nature and level of work expected for the position. It is not intended to be a comprehensive list of all responsibilities, duties, or qualifications. Sun Pharma may modify responsibilities or assign comparable duties based on business requirements and the employee’s experience and background.
Uttar Pradesh :
Agra | Gajraula | Gautam buddha Nagar | Ghaziabad | Gorakhpur | Greater Noida | Jhansi | kanpur | Lucknow | Mathura | Noida | Park City | Prayagraj | Satyamev | Varanasi |Gujarat :
Ahmedabad | Ankleshwar | Baroda | Bharuch | Gandhinagar | Gujarat | Halol | Jhagadia | Mehsana | surat | Tarasadi | Vadodara | Vapi |Maharashtra :
Airoli | Ambernath | Amravati | Aurangabad | Dhule | Dombivali | Jalgaon | Kolhapur | Kurkumbh | Kurla | Madhapur | Mumbai | Nagpur | Nashik | Navi Mumbai | parel | Pune | Pune city | Shirpur | Tandalja | Tarapur | Thane | Vikhroli | Yerawada |Haryana :
Ambala | Gurugram | Haryana | Hisar | Kurukshetra | Panchkula | Rohtak | Shivalik |Punjab :
amritsar | Bathinda | Bela | Chandigarh | ludhiana | Moga | Mohali | Patiala | Phagwara | Punjab | Rajpura |Andra Pradesh :
Anakapali | Anantapur | Bhimavaram | Chittoor | Guntur | Gurgaon | Kakinada | Mangalagiri | Nellore | Pydibimavaram | Tirupathi | Vijayawada | Visakhapatnam |Tamil Nadu :
Annamalainagar | Chennai | Coimbatore | Erode | Madurai | Nagercoil | Ooty | Pudupakkam | Srivilliputtur | Tamil nadu | Tiruchirappalli | tiruppur | Trichy | Vellore | Yogyakarta |Himachal Pradesh :
Baddi | Solan |Rajasthan :
Banasthali | Bhiwadi | Jaipur | Pilani | Udaipur |Karnataka :
Bangalore | Belgaum | Bengaluru | B.G Nagara | Bommasandra | Colorado | Czech Republic | Karnataka | Mangaluru | Mysore | Udupi |Madhya Pradesh :
Bhopal | Dewas | Gwalior | Indore | Khandwa | Khargone | Pithampur | Ujjain |Odisha :
Bhubaneswar | Rourkela |Chhattisgarh :
Bilaspur | Eot Municipality | Raipur |Uttarakhand :
Dehradun | Halifax | Nainital | Rishikesh | Roorkee |Delhi :
Delhi | Gangtok | New Delhi | PAN-India |Assam :
Dibrugarh | Diburghar | Guwahati |West Bengal :
Digha | Kolkata | Mukundapur |Goa :
Goa | Panaji | Verna |Bihar :
Hajipur | Patna |Kerala :
Kannur | Kochi | Malappuram | Thiruvananthapuram | Trivandrum |Pondicherry (Puducherry) :
Pondicherry (Puducherry) |Jharkhand :
Ranchi |Sikkim :
Rangpo |India :
Remote, India | Siliguri |Illinois :
Abbott Park | Bloomingdale | Champaign | Chicago | Deerfield | Glenview | Lake Forest | Lombard | Naperville | Norridge | Park RIdge | Round Lake |Maryland :
Aberdeen | Baltimore | Bel Air | Cheverly | Columbia | Elkridge | Gaithersburg | Largo | Linthicum | Rockville | Towson | Upper Marlboro | White Plains |Texas :
Abilene | Arlington | Austin | Boerne | Brenham | Bulverde | Carrollton | Cedar Hill | Corpus Christi | Corsicana | Dallas | Denton | El Paso | Fort Worth | Garland | Houston | Lakeway | Longview | Mcallen | North Richland Hills | Plano | Richardson | San Antonio | Seguin | Tyler | Waco |California :
Adelanto | Alameda | Albion | Arcata | Atherton | Berkeley | Brisbane | Burlingame | Burney | California | Carlsbad | Crescent City | Davis | Downey | El Monte | El Segundo | Emeryville | Eureka | Fortuna | Foster City | Fremont | Glendale | Hayward | Hoopa | Irvine | La Jolla | Los Angeles | Martinez | McKinleyville | Menlo Park | Millbrae | Milpitas | Morgan Hill | Mountain View | Nevada | Novato | Oakland | Orange | Pacheco | Palo Alto | Pasadena | Pleasanton | Pomona | Redding | Redwood City | Riverside | Roseville | Sacramento | San Bernardino | San Carlos | San Diego | San Francisco | San Gabriel | San Jose | San Mateo | San Rafael | Santa Clara | Santa Cruz | Santa Monica | Simi Valley | Soledad | South San Francisco | Stanford | Stanton | St. Helena | Stockton | Sunnyvale | Temecula | Thousand Oaks | Valencia | Vallejo | West Sacramento | West Valley City | Whittier | Willits |New York :
Albany | Biddle | Brooklyn | Buffalo | Hauppauge | Hawthorne | Hicksville | Ithaca | Middleburgh | Morningside Heights | New York | Pearl River | Poughkeepsie | Rensselaer | Rhinebeck | Syracuse | Utica | Watertown |New Mexico :
Albuquerque | Farmington | Santa Fe | Tucumcari |Pennsylvania :
Ambler | Bethlehem | Collegeville | Harrisburg | Lancaster | Marietta | Middletown | Philadelphia | Pittsburgh | Plymouth Meeting | Pottstown | Radnor | Sellersville | Southampton | Spring House | West Chester | Wyomissing |Alaska :
Anchorage | Barrow | Bethel | Juneau | Sitka | Wrangell |Massachusetts :
Andover | Billerica | Boston | Cambridge | Devens | Lexington | Massachusetts | Medford and Somerville | Rockland |Wisconsin :
Appleton | Kenosha | Pleasant Prairie | Portage | Waukesha |United states :
Arizona | Buffalo Grove | Clayton | Downers Grove | fairmont | Geelong Vic | Georgia | Keene | Michigan | Mt. Pleasant | New Jersy | OH | Piedmont | Salisbury | Whitesboro | Winston-Salem |Georgia :
Atlanta | Augusta | Rome |Maine :
Bangor | Brewer |New Jersey :
Basking Ridge | Bloomfield | Branchburg Township | Bridgewater | Brunswick | Burlington | Charlotte | Clark | Cranbury | Dunellen | East Brunswick | Edison | Fairfield | Far Hills | Flemington | Hackensack | Hopewell | Indianapolis | Jersey City | Linden | Livingston | Lyndhurst | Mahwah | Monmouth Junction | Montville | Mount Arlington | Newark | New Brunswick | Nutley | Paramus | Parsippany | Passaic | Paterson | Peapack-Gladstone | Pine Brook | Piscataway Township | Plainsboro | Princeton Junction | Rahway | Raritan | Somerset | Somerville | South Plainfield | Sparta | Summit | Titusville | Trenton | Warren Grove | Westfield | West Orange | Wharton | Whippany |Ohio :
Batavia | Blue Ash | Cincinnati | Cleveland | Columbus, | Dayton | Erie | Evendale | Franklin | Hamilton | Huber Heights | Kings Mills | Macedonia | Mason | Milford | Montgomery | Norwood | Oregoina | oxford | Waynesville |LA :
Baton Rouge | Monroe | New Orleans |Washington :
Bellevue | Bothell | Friday Harbor | Goldendale | Mount Vernon | Pullman | Seattle | Sherwood | Tacoma | Vancouver |Oregon :
Bend | Coquille | Corvallis | Eugene | Florence | Grants Pass | John Day | Lake Oswego | Lakeview | Portland | Reedsport | Roseburg | Salem | Springfield | Woodburn |Wyoming :
Big Piney | Cokeville |Alabama :
Birmingham |Virginia :
Blacksburg | Charlottesville | Falls Church | Mechanicsville |Indiana :
Bloomington | West Lafayette |Florida :
Boca Raton | Brooksville | Clearwater | Cooper City | Coral Gables | Coral Springs | Daytona Beach | Florida | Gainesville | Hollywood | Jacksonville | Maitland | Marsa | Miami | Naples | North Miami Beach | Orlando | Pembroke Pines | Plantation | Port St. Lucie | Rueil-Malmaison | Saint Petersburg | Sarasota | Stuart | Tallahassee | Tampa | West Palm Beach | Winter Haven |Idaho :
Boise |Colorado :
Boulder | Denver | Westminster |Connecticut :
Bridgeport | Bristol | Enfield | Groton | Hartford | New Haven | Newtown | South Windsor | Stamford | Storrs | West Hartford |North Caroline :
Carolina Beach | Chapel Hills | Durham | Holly Springs | Morrisville | Philippines | Raleigh | Rocky Mount | Sanford | Scottsdale |Arizona :
Chandler | Kingman | Lake Havasu City | Mesa | Peridot | Phoenix | Surprise | Tempe | Tucson | Yuma |South Carolina :
Charleston |Kansas :
Chengdu | Garden city | Kansas City | Lawrence | McPherson |North Carolina :
Concord | Lumberton | North Carolina |Michigan :
Detroit | Houghton Lake | Macomb | Southfield |North Dakota :
Dickinson |Minnesota :
Duluth | Eden Prairie | Fridley | Hibbing | Maple Grove | Minneapolis and St. Paul, Minnesota. | Minnetonka | St.Paul |Kentucky :
Edgewood | Ft MItchell | Louisville | Shelbyville |Arkansas :
Fort Smith |Kington :
Frank Scottile Blvd |Missouri :
Fulton | Milan | St. Louis |United States :
Hawai | kentucky | Sylmar | Woonsocket |Nebraska :
Hebron | Nebraska City |Hawaii :
Hilo | Honolulu |Tennessee :
Knoxville | Memphis | Nashville |Louisiana :
Lake Charles | Shreveport |Nevada :
Las Vegas | Tonopah | Tonopsh | Virginia |New Hampshire :
Lebanon | Macon | Manchester |Portugal :
Lisbon | Oeiras | Portugal |WI :
Madison | Wausau |Republic of Mexico :
Mexico |northeastern :
New Hampshire |Oklahoma :
Oklahoma City |Puerto Rico :
San Juan |Albama :
Tuscaloosa |D.C :
Washington |Delaware :
Wilmington |North Rhine Westphalia :
Aachen | Bielefeld | Bochum | Bonn | Cologne | Dortmund | Duisburg | Dusseldorf | Munster |Munich :
Bavaria |Bavaria :
Bayreuth | Erlangen | Munich | Regensburg | Wurzburg |Brandenburg :
Berlin |Baden-Wurttemberg :
Biberach an der Riß | Freiburg | Grenzach | Heidelberg | Karlsruhe | Konstanz | Stuttgart | Tubingen | Ulm |Hesse :
Darmstadt | Marburg |Hessen :
Frankfurt | Harveysburg |Germany :
Germany | GErmany |Lower Saxony :
Gottingen | Hannover | Leipzig |Saxony Anhalt :
Halle |Rotherbaum :
Hamburg |Rhineland Palatinate :
Ingelheim am Rhein | Mainz |Schleswig Holstein :
Kiel |Berlin :
Mitte |Mecklenburg Vorpommern :
Rostock |Saarland :
Saarbrucken |Switzerland :
Basel | Zurich |Serbia :
Belgrade | Serbia |Hungary :
Budapest |BULGARIA :
Bulgaria | Vedant |Denmark :
Copenhagen | Denmark |Europe :
Europe | France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
Finland |Istanbul :
Istanbul | Turkey |Norway :
Norway | NOrway |Romania :
Romania |Belgium :
Wavre |Tipperary :
Ballydine |Cork :
Brinny | Ringaskiddy |Carlow :
Carlow |Republic of Ireland :
Cork | Dublin | Limerick | Waterford |Ulster :
Donegal |Meath :
Dunboyne |Dún Laoghaire :
Dún Laoghaire |Galway :
Galway |County Dublin :
Swords |Republic of China :
Beijing |China :
China | Quarry Bay |Liaoning :
Dalian |Zhejiang :
Hangzhou |Tokiyo :
Osaka | Tokyo |Shanghai Sai :
Shanghai Shi |Hubei :
Wuhan |Capital of Netherland :
Amsterdam |North Brabant :
Breda |Noord Holland :
Haarlem |South Holland :
Leiden |Netherlands :
Netherlands |Remote Australia :
Arkansas | Remote Australia |New South Wales :
Ballina | Sydney |Republic of Western Australia :
Nedlands |Queensland :
Queensland |Melbourne :
South Yarra |United Kingdom :
England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |North Yorkshire :
Harrogate |South Yorkshire :
Sheffield |Oxfordshire :
Witney |Ontario :
Mississauga | Australia | Richmond Hill | North York | Renfrew | Uxbridge |Canada :
Canada |Quebec :
Montreal |Brussels :
Brussels |Antwerp :
Heist op den Berg |Flemish Brabant :
Zaventem |South America :
Peru | Argentina |Brazil :
Sao paulo | Brazil |Attica :
Athens | Koropi |Greece :
Greece |North Island :
Auckland |New Zealand :
New Zealand |Austria :
Austria |Vienna :
Vienna |Catalonia :
Barcelona |Madrid :
Madrid |Cebu Province :
Cebu City |Philippines :
Manila |Croatia :
Croatia |Zagreb :
Zagreb |Estonia :
Tartu | Estonia |Harju County (Maakond) :
Tallinn |Hà Nội :
Hanoi | Hà Nội |Ho Chi Minh :
Ho Chi Minh City |Italy :
Italy |Lombardy :
Rho |Jakarta :
Jakarta |East Java :
Surabaya |Japan :
Japan | Saitama |Tokyo :
Otemachi |North Ostrobothnia :
Oulu |Southwest Finland (Varsinais-Suomi) :
Turku |Remote Korea :
Remote Korea |Republic of Korea :
Seoul |Kazakhstan :
Almaty |Republic of Thailand :
Bangkok |Israel :
Yavne | Kfar Saba | Be'Er Sheva | Tel Aviv | Netanya |Remote :
Remote - South America (Latin Americal) | Switzerland | Bountiful | Victoria | Castlebar | Milwaukee | Thailand | Lousiana | Faridabad | Melbourne | Tulsa | Green Way | Riga | Hungary | Remote - Middle East | Lenexa | Manipal | Minnesota | Medan | Perth | Bishop | Regulatory Labeling Manager (NA and LATAM Only) | Texas | Blue Bell | Ireland | Slovakia | French | Belgium | McFarland | Nairobi | Springville | Hammond | Xzagreb | Remote - Europe | Leinster | Zaragoza | Remote - Africa |Republic of Colombia :
Bogota |Williamson :
Brentwood |Bucharest :
Bucharest |Buenos Aires :
Buenos Aires |Republic of Egypt :
Cairo |Mexico :
New Mexico | Ciudad de México |Dubai :
Dubai |Makkah :
Riyadh | Khulais | Jeddah | King Abdullah Economic City | Rabigh | Najran |Kuala Lumpur :
Kuala Lumpur |Kyiv Oblast :
Kyiv |Lima Region :
Lima |France :
Paris | Lyon |South Africa :
Midrand | South Africa |Nišava District :
Niš |Bohemia :
Prague |Chile :
Santiago |Bosnia and Herzegovina :
Sarajevo |Singapore :
Singapore |Sofia City :
Sofia |Sweden :
Sweden |Taipei :
Taipei |Mazovia :
Warsaw |
Sign in with Google
