{"id":2499323,"url":"https://alion.io/job/dr-reddys-laboratories-quality-assurance-associate-2","title":"Quality Assurance Associate","company":{"id":5190,"name":"Dr. Reddy's Laboratories","domain":"drreddys.com","url":"https://alion.io/company/dr-reddy-s-laboratories-limited","size_band":"5000+","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"SmartRecruiters","truth_index":null},"role":"Industrial Engineering","role_family":"Industrial Engineering","seniority":"senior","employment_type":"full_time","work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Hyderabad, India"],"countries":["IN"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":9000,"max_usd":26000,"period":"year","method":"role_seniority_country_remote_cell","sample_n":31},"experience_years_min":6,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[],"status":"closed","first_seen_at":"2026-10-14T04:33:35Z","employer_posted_date":"2026-10-14","last_verified_at":"2026-10-20T22:26:16Z","board_verified":false,"closed_at":"2026-10-20T22:26:16Z","days_open":6,"trust":{"level":"not_scored","repost_count":null,"flags":[],"days_open":6},"description":"Dr. Reddy’s Laboratories Ltd. is a leading multinational pharmaceutical company based across global locations. Each of our 24,000 plus employees comes to work every day for one collective purpose: to accelerate access to affordable and innovative medicines because Good Health Can’t Wait.\nWe started in 1984 with a modest investment, 20 employees and a bold vision. Today, we have research and development centres, manufacturing facilities or a commercial presence in 66 countries.\nFor nearly four decades, we have stood for access, affordability and innovation based on the bedrock of deep science, progressive people practices and robust corporate governance. As the pharmaceutical industry evolves and undergoes disruption, we see an opportunity - to strengthen our core further (the next steps) and to build the future (the new bets).\n‘The Next and the New’ is how we aim to continue to be the partner of choice - purpose-driven, future-ready and sustainable. Our aim is to reach over 1.5 Bn+ patients across the world by 2030 by growing our core businesses and building for the future with sustainability at the core of our purpose and strategy. Sustainability for us means operating in a manner that respects people, planet and purpose - helping us conserve precious resources, serve our patients, create value for stakeholders, give back to society, fulfil our potential and maintain our integrity and transparency\nDr Reddy’s maintains a work environment, free from discrimination and is an equal opportunity employer. We are committed to employ & nurture all qualified diverse workforce without regard to race, colour religion, nationality, sex, age, disability status, genetics, sexual orientation, gender expression, citizenship or any other characteristic or classification protected by applicable law(s) of the country we operate in. We treasure every talent, and recognize merit and diversity in our organization.\n\"\n Job Summary\nWe are seeking an individual to verify compliance for activities in the respective counter function regularly. This role involves reviewing real-time investigations, ensuring smooth batch manufacturing and testing activities, and evaluating practices against defined standards, to ensure consistent product quality and operational compliance within the regulatory framework and global standards.\nKey Responsibilities - Drug Substance Quality Assurance (DS-QA)\nCell Bank Assurance\n\nOversee the qualification, documentation, and traceability of Master and Working Cell Banks (MCB/WCB).\n\nEnsure compliance with GMP, EU Annex 1, and ICH guidelines for cell bank handling, storage, and distribution.\n\nReview and approve cell bank-related protocols, COAs, and characterization reports.\n\nMonitor environmental conditions and alarm systems for cell bank storage units (LN2 tanks, freezers).\n\nSupport audits and regulatory inspections by providing cell bank documentation and responses.\n\nCoordinate with manufacturing, QC, and regulatory teams to ensure cell bank readiness for production.\n\nManage deviations, CAPAs, and change controls related to cell bank operations.\n\nIssue Work Cell Banks (WCB) and Master Cell Banks (MCB) as per requirements.\n\nBatch Production Record (BPR) Review & Documentation\nReview executed Drug Substance (DS) BPRs and associated documents for all products.\nEnsure timely deposition of reviewed documents to the DCQA.\n\nDocument Review & Approval\nReview and approve Master Formula Records (MFRs), BPRs, Bill of Materials (BOMs), Standard Operating Procedures (SOPs), Product Quality Reviews (PQRs), action plans, and other relevant documents for both existing and new products.\n\nProtocol & Report Evaluation\nReview and approve various protocols and reports, including technology transfer documents related to DS manufacturing processes.\n\nQuality Systems Oversight\nInitiate, review, and approve investigations, discrepancies, Corrective and Preventive Actions (CAPAs), Change Controls, and Quality Risk Management (QRM) activities.\n\nAudit Support\nProvide support during internal and external audits.\nEnsure timely closure of audit observations and implementation of corrective actions.\n\nGMP Compliance Monitoring\nMonitor shop floor activities to ensure compliance with Good Manufacturing Practices (GMP).\nConduct routine and non-routine spot checks.\n\nLine Clearance & Critical Activity Oversight\nProvide line clearance for product changeovers and oversee critical activities as per SOPs across DS facilities.\n\nSOP & Document Management\nCreate, revise, and review SOPs, forms, and other DS-QA-related documents as required.\n\nGMP Record Verification\nPerform periodic verification of GMP records in alignment with ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, plus Complete, Consistent, Enduring, and Available).\n\nQualification & Validation Review\nReview and approve process and cleaning qualification/validation protocols and reports.\n\nAudit Trail Review\nReview system and process audit trails as per the defined schedule.\nPerform audit trail reviews for equipment.\n\nIssuance of Cell Banks for Manufacturing Operation\n\nIssue Working and Master Cell Banks to Manufacturing as per approved guidelines, ensuring traceability and compliance.\n\n Educational qualification: M.sc (Life Science) /M Pharm\nMinimum work experience: 6-8 years of industrial experience with specific operational experience in Quality Assurance and Manufacturing (Biosimilars)\nSkills & attributes:\nTechnical Skills\nA solid understanding of Quality Systems and the ability to comprehend and navigate counter functions within the organization.\nIn-depth knowledge and comprehension of the Bio Pharma and Pharma markets, including product knowledge, market trends, competitors, and customer needs.\nUnderstanding and familiarity with global cGMP (Current GMP) regulatory requirements, including those set by FDA (U.S. Food and Drug Administration), EU (European Union), and Indian regulatory authorities.\nAwareness of broader market dynamics, industry trends, and factors influencing the pharmaceutical market.\nComprehensive knowledge of the specific products associated with the pharmaceutical organization, including their characteristics, manufacturing processes, and quality requirements.\nAbility to understand and implement organizational policies and ensuring compliance.\nBehavioural skills\nDemonstrates a commitment to continuous learning.\nStrong communicating and influencing skills.\nDisplays analytical and logical thinking abilities.\nSelf-motivated and takes initiative.\nAdaptability to the work environment, along with being a team player.\nAbility to go beyond boundaries, showcasing a proactive and innovative approach.\nShift Flexibility\nDemonstrate the ability and willingness to work in rotational shifts, including night shifts, weekends, and holidays, as per operational requirements to ensure continuous QA oversight and compliance.\n About the Department : Biologics\nCurrently operates in the Global Biosimilars business - a segment that is poised for attractive and sustained growth over the next 10-15-year time horizon...\n\" Benefits Offered\nAt Dr. Reddy’s, we actively help to catalyze your career growth and professional development through personalized learning programs. The benefits you will enjoy at Dr. Reddy’s are on par with the best industry standards...\n\" Our Work Culture\nAsk any employee at Dr. Reddy’s why they come to work every day and they’ll say, because Good Health Can’t Wait. This is our credo as well as the guiding principle behind all our actions...\nFor more details, please visit our career website at https://careers.drreddys.com/#!/\nVideos to Watch","description_format":"text","description_chars":7648,"description_truncated":false,"requirements":{"experience_years_min":6,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"master","optional":false},"security_clearance":false,"languages":[{"language":"English","level":"All levels","optional":false}]},"benefits":["Continuous learning","Professional development"],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Prescription Drugs","Biologics & Biosimilars","OTC & Consumer Health Products","APIs & Drug Manufacturing"],"lifecycle":[{"event":"open","at":"2026-10-14T05:32:16Z"},{"event":"close","at":"2026-10-20T22:26:16Z"}],"visa":[],"liveness":null,"pay":null,"html_url":"https://alion.io/job/dr-reddys-laboratories-quality-assurance-associate-2","json_url":"https://alion.io/job/dr-reddys-laboratories-quality-assurance-associate-2.json","meta":{"generated_at":"2026-10-21T06:09:12Z","cache_seconds":300,"methodology":"https://alion.io/methodology","terms":"https://alion.io/terms","contact":"https://alion.io/contact","api":"https://alion.io/developers","about":"Alion is a live layer of people, companies and AI agents: who they are, whether they are real and active right now, what they do and how to work with them, readable by people and by agents and paid per call.","catalog":"https://alion.io/catalog.json","usage":{"tier":"crawler_verified","counted_by":"address","units_charged":1,"used_today":8940,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-22T00:00:00Z"}},"offers":[{"id":"company.slices","title":"One company in depth, by slice","status":"live","price":{"credits":0.02,"usd":0.002,"plus_per_slice":{"credits":0.05,"usd":0.005}},"unit":"per company, plus each slice with data","note":"the employer in depth","call":{"mcp_tool":"get_company","arguments":{"id":5190},"rest":"https://alion.io/mcp/rest/get_company?id=5190"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fdr-reddys-laboratories-quality-assurance-associate-2"},{"id":"market.stats","title":"A market slice: pay, demand and time to fill","status":"live","price":{"credits":1,"usd":0.1},"unit":"per slice","note":"pay, demand and time to fill for this role and place","call":{"mcp_tool":"market_stats"},"human":"https://alion.io/catalog?offer=market.stats&for=job%2Fdr-reddys-laboratories-quality-assurance-associate-2"},{"id":"job.search","title":"Open jobs by role, technology, place, pay and visa","status":"live","price":{"credits":0.02,"usd":0.002},"unit":"per posting in a list","note":"similar open postings","call":{"mcp_tool":"search_jobs"},"human":"https://alion.io/catalog?offer=job.search&for=job%2Fdr-reddys-laboratories-quality-assurance-associate-2"},{"id":"company.verify","title":"Is this company real and active right now","status":"pilot","price":null,"unit":"per company","request":{"url":"https://alion.io/catalog/request","method":"POST","body":"{\"offer\": \"company.verify\", \"for\": \"job/dr-reddys-laboratories-quality-assurance-associate-2\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fdr-reddys-laboratories-quality-assurance-associate-2"}]}