Executive – Late Phase QA
Company: Lambda Therapeutic Research Ltd.
Req ID: 1312
Location: Ahmedabad, India
Date Posted: 19 Oct 2025
CTC Range: ₹5,00,000 – ₹9,00,000 per annum
Company Overview
Lambda Therapeutic Research is a global full-service Clinical Research Organization (CRO) headquartered in Ahmedabad, India, with facilities in:
Mehsana (India)
Las Vegas (USA)
Toronto (Canada)
Barcelona (Spain)
London (UK)
Warsaw (Poland)
Lambda provides end-to-end clinical research services to innovator, biotech, and generic pharmaceutical industries worldwide.
Job Summary
The Executive – Late Phase QA is responsible for ensuring that all late-phase clinical trial activities are conducted in full compliance with regulatory requirements, Lambda SOPs, and sponsor specifications. The role includes conducting audits, supporting inspections, reviewing study documentation, and driving quality excellence across assigned projects.
Key Responsibilities
1. Clinical Trial Audits & Compliance
Conduct in-process, on-site, and off-site audits to ensure accurate conduct, data recording, analysis, and reporting.
Perform retrospective audits of study documents such as:
Informed Consent Forms
Clinical Protocol
Project Management Plan
IMP-related documents
Safety Management Plan (SMP)
Clinical Study Report (CSR)
Medical Imaging documents
2. System Audits
Conduct and report system audits as per annual audit calendar.
Ensure compliance with:
Lambda SOPs
Quality Systems
Protocols
Regulatory requirements
3. Inspection & Sponsor Audit Support
Support Head-QA/Designee during regulatory inspections and sponsor audits.
Arrange and compile required data for inspections.
Provide audit and inspection support to project teams.
Review and provide inputs for sponsor query responses.
Facilitate site-level regulatory inspections in collaboration with operations teams.
4. SOP & Document Review
Prepare and review QA SOPs.
Review system SOPs (CTM, MI, CTM-MS) and departmental work instructions for compliance and adequacy.
5. Risk Management & Reporting
After audit completion, prepare risk analysis of findings.
Suggest mitigation strategies to concerned departments.
Share compliance reports with management.
Regularly update Head-QA/Designee on compliance status.
6. Project & Vendor Audit Planning
Plan and coordinate on-site audits for applicable projects.
Manage vendor audits as required.
7. Documentation & Trend Analysis
Compile and update internal trackers/databases.
Perform trend analysis on compliance metrics.
Audit:
Trial Master File (TMF)
Site Master File (SMF)
Protocol deviation tracker
SAE tracker
Experience Required
3–5 years of experience in Clinical Research/Quality Assurance.
Educational Qualification
M.Pharm
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Anakapali | Anantapur | Bhimavaram | Chittoor | Guntur | Gurgaon | Mangalagiri | Nellore | Pydibimavaram | Tirupathi | Vijayawada | Visakhapatnam |Assam :
Dibrugarh | Diburghar | Guwahati |Bihar :
Hajipur | Patna |Chhattisgarh :
Bilaspur | Eot Municipality | Raipur |Delhi :
Delhi | India | New Delhi | PAN-India |Goa :
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B.G Nagara | Bangalore | Belgaum | Bengaluru | Bommasandra | Colorado | Czech Republic | Karnataka | Mangaluru | Mysore | Udupi |Kerala :
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Bhopal | Dewas | Gwalior | Indore | Khandwa | Khargone | Pithampur | Ujjain |Maharashtra :
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Pondicherry (Puducherry) |Punjab :
Bathinda | Bela | Chandigarh | ludhiana | Moga | Mohali | Patiala | Phagwara | Rajpura |Rajasthan :
Banasthali | Bhiwadi | Jaipur | Pilani | Udaipur |Sikkim :
Rangpo |Tamil Nadu :
Annamalainagar | Chennai | Coimbatore | Erode | Madurai | Nagercoil | Ooty | Pudupakkam | Srivilliputtur | Tiruchirappalli | Trichy | Vellore | Yogyakarta |Uttar Pradesh :
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Digha | Kolkata | Mukundapur |Alabama :
Birmingham |Alaska :
Anchorage | Barrow | Bethel | Juneau | Sitka | Wrangell |Albama :
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Chandler | Kingman | Lake Havasu City | Mesa | Peridot | Phoenix | Surprise | Tempe | Tucson | Yuma |Arkansas :
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Wilmington |Florida :
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Atlanta | Augusta | Rome |Hawaii :
Hilo | Honolulu |Idaho :
Boise |Illinois :
Abbott Park | Bloomingdale | Champaign | Chicago | Deerfield | Glenview | Lake Forest | Lombard | Naperville | Norridge | Park RIdge | Round Lake |Indiana :
Bloomington | West Lafayette |Kansas :
Chengdu | Garden city | Kansas City | Lawrence | McPherson |Kentucky :
Edgewood | Ft MItchell | Louisville | Shelbyville |Kington :
Frank Scottile Blvd |LA :
Baton Rouge | Monroe | New Orleans |Louisiana :
Lake Charles | Shreveport |Maine :
Bangor | Brewer |Maryland :
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Andover | Billerica | Boston | Cambridge | Devens | Lexington | Massachusetts | Medford and Somerville | Rockland |Michigan :
Detroit | Houghton Lake | Macomb | Southfield |Minnesota :
Duluth | Eden Prairie | Fridley | Hibbing | Maple Grove | Minneapolis and St. Paul, Minnesota. | Minnetonka | St.Paul |Missouri :
Fulton | Milan | St. Louis |Nebraska :
Hebron | Nebraska City |Nevada :
Las Vegas | Tonopah | Tonopsh | Virginia |New Hampshire :
Lebanon | Macon | Manchester |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 | New Brunswick | Newark | 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 | West Orange | Westfield | Wharton | Whippany |New Mexico :
Albuquerque | Farmington | Santa Fe | Tucumcari |New York :
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Dickinson |northeastern :
New Hampshire |Ohio :
Batavia | Blue Ash | Cincinnati | Cleveland | Columbus, | Dayton | Erie | Evendale | Franklin | Hamilton | Huber Heights | Kings Mills | Macedonia | Mason | Milford | Montgomery | Norwood | Oregoina | oxford | Waynesville |Oklahoma :
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Mexico |South Carolina :
Charleston |Tennessee :
Knoxville | Memphis | Nashville |Texas :
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Arizona | Buffalo Grove | Clayton | Downers Grove | fairmont | Georgia | Keene | Michigan | Mt. Pleasant | New Jersy | OH | Piedmont | Salisbury | United States | Whitesboro | Winston-Salem |United States :
Hawai | kentucky | Sylmar | Woonsocket |Virginia :
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Big Piney | Cokeville |Baden-Wurttemberg :
Biberach an der Riß | Freiburg | Grenzach | Heidelberg | Karlsruhe | Konstanz | Stuttgart | Tubingen | Ulm |Bavaria :
Bayreuth | Erlangen | Munich | Regensburg | Wurzburg |Berlin :
Mitte |Brandenburg :
Berlin |Germany :
Germany | GErmany |Hesse :
Darmstadt | Marburg |Hessen :
Frankfurt | Harveysburg |Lower Saxony :
Gottingen | Hannover | Leipzig |Mecklenburg Vorpommern :
Rostock |Munich :
Bavaria |North Rhine Westphalia :
Aachen | Bielefeld | Bochum | Bonn | Cologne | Dortmund | Duisburg | Dusseldorf | Munster |Rhineland Palatinate :
Ingelheim am Rhein | Mainz |Rotherbaum :
Hamburg |Saarland :
Saarbrucken |Saxony Anhalt :
Halle |Schleswig Holstein :
Kiel |Belgium :
Wavre |BULGARIA :
Bulgaria | Vedant |Denmark :
Copenhagen | Denmark |Europe :
France | Latvia | Lendava | Leuven | Poland | Slovenia | Spain |Finland :
Finland |Hungary :
Budapest |Istanbul :
Istanbul | Turkey |Norway :
Norway | NOrway |Romania :
Romania |Serbia :
Belgrade | Serbia |Switzerland :
Basel | Zurich |Carlow :
Carlow |Cork :
Brinny | Ringaskiddy |County Dublin :
Swords |Dún Laoghaire :
Dún Laoghaire |Galway :
Galway |Meath :
Dunboyne |Republic of Ireland :
Cork | Dublin | Limerick | Waterford |Tipperary :
Ballydine |Ulster :
Donegal |China :
China | Quarry Bay |Hubei :
Wuhan |Liaoning :
Dalian |Republic of China :
Beijing |Shanghai Sai :
Shanghai Shi |Tokiyo :
Osaka | Tokyo |Zhejiang :
Hangzhou |Melbourne :
South Yarra |New South Wales :
Ballina | Sydney |Queensland :
Queensland |Remote Australia :
Arkansas | Remote Australia |Republic of Western Australia :
Nedlands |Capital of Netherland :
Amsterdam |Netherlands :
Netherlands |Noord Holland :
Haarlem |North Brabant :
Breda |South Holland :
Leiden |North Yorkshire :
Harrogate |Oxfordshire :
Witney |South Yorkshire :
Sheffield |United Kingdom :
England | Harlow | Leeds | London | Maidenhead | Salt Lake City | Stevenage | Stirling | United Kingdom |Buenos Aires :
Buenos Aires |Austria :
Austria |Vienna :
Vienna |Antwerp :
Heist op den Berg |Brussels :
Brussels |Flemish Brabant :
Zaventem |Bosnia and Herzegovina :
Sarajevo |Sofia City :
Sofia |Canada :
Canada |Ontario :
Australia | Richmond Hill | Mississauga | Uxbridge | Renfrew | North York |Quebec :
Montreal |Chile :
Santiago |Republic of Colombia :
Bogota |Croatia :
Croatia |Zagreb :
Zagreb |Bohemia :
Prague |Republic of Egypt :
Cairo |Estonia :
Estonia | Tartu |Harju County (Maakond) :
Tallinn |Chuuk :
North Ostrobothnia :
Oulu |Southwest Finland (Varsinais-Suomi) :
Turku |France :
Paris | Lyon |Attica :
Koropi | Athens |Greece :
Greece |East Java :
Surabaya |Jakarta :
Jakarta |Israel :
Kfar Saba | Netanya | Be'Er Sheva | Tel Aviv | Yavne |Italy :
Italy |Lombardy :
Rho |Japan :
Saitama | Japan |Tokyo :
Otemachi |Kazakhstan :
Almaty |Remote Korea :
Remote Korea |Republic of Korea :
Seoul |Kuala Lumpur :
Kuala Lumpur |Mexico :
Ciudad de México |New Zealand :
New Zealand |North Island :
Auckland |Lima Region :
Lima |Cebu Province :
Cebu City |Philippines :
Manila |Mazovia :
Warsaw |Remote :
Nairobi | Blue Bell | French | Remote - Europe | Bishop | Riga | Hammond | Slovakia | Zaragoza | Remote, USA | Tulsa | Xzagreb | Lousiana | Springville | Switzerland | Remote - Middle East | Remote - South America (Latin Americal) | Manipal | Thailand | Leinster | Lenexa | Hungary | Bountiful | McFarland | Medan | Green Way | Belgium | Castlebar | Minnesota | Victoria | Melbourne | Texas | Faridabad | Remote - Africa | Ireland | Remote |Bucharest :
Bucharest |Makkah :
King Abdullah Economic City | Rabigh | Riyadh | Najran | Khulais | Jeddah |Nišava District :
Niš |Singapore :
Singapore |South Africa :
South Africa | Midrand |Brazil :
Sao paulo | Brazil |South America :
Peru | Argentina |Catalonia :
Barcelona |Madrid :
Madrid |Sweden :
Sweden |Taipei :
Taipei |Williamson :
Brentwood |Republic of Thailand :
Bangkok |Kyiv Oblast :
Kyiv |Dubai :
Dubai |Hà Nội :
Hà Nội | Hanoi |Ho Chi Minh :
Ho Chi Minh City |