Quality Assurance Associate – Biologics
Quality Assurance – Biosimilars Division
Location: Shamirpet
Department: Biologics – Quality Assurance
Company: Dr. Reddy’s Laboratories
Company Overview
Dr. Reddy’s Laboratories is a global pharmaceutical organization focused on delivering affordable and innovative medicines across the world.
Key Highlights
Founded in 1984
Presence in 66 countries
24,000+ employees globally
Strong focus on:
Biosimilars and biologics innovation
Regulatory compliance
Global quality standards
Sustainable healthcare access
Department Overview – Biologics
The Biologics division is part of the company’s global biosimilars business, focusing on complex biologic medicines.
Key Strengths:
End-to-end biologics development capabilities
In-house clone and process development
Upstream & downstream manufacturing expertise
Bioanalytical and formulation development
Global clinical and regulatory capabilities
Commercial-scale biosimilar manufacturing
Products reaching multiple global markets
Job Summary
The Quality Assurance Associate ensures compliance and quality oversight of manufacturing and testing activities in biologics production.
The role focuses on:
Real-time GMP compliance monitoring
Batch manufacturing and documentation review
Quality system adherence (QMS)
Deviation investigation and CAPA support
Audit readiness and compliance tracking
Key Responsibilities
1. Manufacturing Floor QA Oversight
Execute or assign in-process QA activities during shifts
Perform:
Line clearance checks
Material verification
Machine start-up verification
Sampling coordination
Ensure product quality during manufacturing operations
2. Batch Documentation & Record Review
Execute or review:
Batch manufacturing records (BMRs)
Logbooks and production documentation
QA review sheets
Ensure accurate and compliant documentation practices
Support online documentation systems and record integrity
3. GMP & Facility Compliance
Verify adherence to:
cGMP standards
Facility hygiene and upkeep
Environmental controls
Material segregation
Status labeling systems
Report and escalate deviations through incident systems
4. Quality Management System (QMS) Monitoring
Ensure compliance with:
Change control
Incident management
CAPA systems
Track and support deviation resolution processes
5. Deviation & Investigation Support
Assist in investigations of:
Complaints
Batch failures
OOS/OOT results
Deviations and incidents
Collect data and support root cause analysis
Help document CAPA actions and track effectiveness
6. Audit Support & Compliance
Support internal and external audits
Provide required documentation and clarifications
Track audit observations and ensure timely closure of actions
Coordinate with cross-functional teams for audit responses
Educational Qualifications
Bachelor of Pharmacy (B.Pharm) OR
Post-Graduation in Life Sciences
Experience Requirements
Minimum 5 years of industrial experience
Exposure to one or more of the following:
Manufacturing
Quality Assurance
Quality Control
Pharmaceutical development
Technical Skills
Quality Systems & Compliance
Strong understanding of:
GMP / cGMP systems
Quality Management Systems (QMS)
Regulatory requirements (FDA, EU, Indian authorities)
Manufacturing & Biopharma Knowledge
Understanding of:
Biologics and biosimilar processes
Pharma manufacturing workflows
Product lifecycle and quality requirements
Market and industry trends
Documentation & Systems
Batch record review
Deviation documentation
CAPA systems
Audit documentation handling
Behavioral Competencies
Continuous learning mindset
Strong communication and influencing skills
Analytical and logical thinking ability
Self-driven and proactive approach
Strong teamwork and collaboration
Adaptability to dynamic manufacturing environments
Innovative and solution-oriented mindset
About Biologics Division
Dr. Reddy’s Laboratories Biologics business focuses on biosimilars development and commercialization.
Key Highlights:
Covers high-value biologics market (~$80B+ innovator sales exposure)
Over 900,000 patients served globally
Strong pipeline of biosimilar products
Global regulatory and clinical capabilities
High-quality, cost-efficient manufacturing systems
Benefits & Employee Support
Competitive compensation and benefits
Medical coverage for employees and families
Life insurance coverage
Maternity & paternity benefits
Learning and development programs
Relocation support
Work Culture
Dr. Reddy’s Laboratories promotes:
Patient-first mindset (“Good Health Can’t Wait”)
Strong quality and compliance culture
Collaboration and teamwork
Continuous improvement mindset
Inclusive and diverse workforce
Uttar Pradesh :
Agra | Gajraula | Gautam buddha Nagar | Ghaziabad | Gorakhpur | Greater Noida | Jhansi | kanpur | Lucknow | Mathura | Noida | Park City | Prayagraj | Satyamev | Varanasi |Gujarat :
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Delhi | Gangtok | New Delhi | PAN-India |Assam :
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Goa | Panaji | Verna |Bihar :
Hajipur | Patna |Kerala :
Kannur | Kochi | Malappuram | Thiruvananthapuram | Trivandrum |Pondicherry (Puducherry) :
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Remote, India | Siliguri |Illinois :
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Duluth | Eden Prairie | Fridley | Hibbing | Maple Grove | Minneapolis and St. Paul, Minnesota. | Minnetonka | St.Paul |Kentucky :
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Frank Scottile Blvd |Missouri :
Fulton | Milan | St. Louis |United States :
Hawai | kentucky | Sylmar | Woonsocket |Nebraska :
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Hilo | Honolulu |Tennessee :
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Lisbon | Oeiras | Portugal |WI :
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Mexico |northeastern :
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Oklahoma City |Puerto Rico :
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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 :
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Hamburg |Rhineland Palatinate :
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Saarbrucken |Switzerland :
Basel | Zurich |Serbia :
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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 :
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China | Quarry Bay |Liaoning :
Dalian |Zhejiang :
Hangzhou |Tokiyo :
Osaka | Tokyo |Shanghai Sai :
Shanghai Shi |Hubei :
Wuhan |Capital of Netherland :
Amsterdam |North Brabant :
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Netherlands |Remote Australia :
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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 :
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Renfrew | Uxbridge | Mississauga | Richmond Hill | North York | Australia |Canada :
Canada |Quebec :
Montreal |Brussels :
Brussels |Antwerp :
Heist op den Berg |Flemish Brabant :
Zaventem |South America :
Peru | Argentina |Brazil :
Brazil | Sao paulo |Attica :
Koropi | Athens |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 :
Estonia | Tartu |Harju County (Maakond) :
Tallinn |Hà Nội :
Hanoi | Hà Nội |Ho Chi Minh :
Ho Chi Minh City |Italy :
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Japan | Saitama |Tokyo :
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Kyiv |Lima Region :
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