{"id":1468360,"url":"https://alion.io/job/sun-pharma-senior-executive-rd-quality-cmc-qa","title":"Senior Executive R&D Quality CMC QA","company":{"id":1808960,"name":"Sun Pharma","domain":"sunpharma.com","url":"https://alion.io/company/sun-pharma","size_band":"1001-5000","is_staffing_agency":false,"employer_type":"direct","is_intermediary":false,"listed_via":null,"ats_vendor":"SuccessFactors","truth_index":null},"role":"QA","role_family":"QA","seniority":"senior","employment_type":null,"work_mode":"on_site","remote_scope":null,"remote_scope_basis":null,"remote_working_hours":null,"hiring_geo_confidence":"structured","locations":["Vadodara, India"],"countries":["IN"],"hiring_countries":[],"hiring_countries_total":0,"salary":null,"salary_estimate":{"min_usd":15000,"max_usd":38000,"period":"year","method":"role_seniority_country_remote_cell","sample_n":35},"experience_years_min":8,"visa_sponsorship":false,"relocation_package":false,"has_equity":false,"technologies":[],"status":"live","first_seen_at":"2026-09-29T15:30:21Z","employer_posted_date":"2026-09-29","last_verified_at":"2026-10-26T02:12:16Z","board_verified":true,"closed_at":null,"days_open":26,"trust":{"level":"ok","repost_count":null,"flags":[],"days_open":26},"description":"Job Title:\n\nSr.Executive - R&D Quality CMC QA_Biotech\n\nBusiness Unit:\n\nGlobal Quality & Compliance\n\nJob Grade\n\nG11B\n\nLocation :\n\nBaroda\n\nAt Sun Pharma, we commit to helping you “Create your own sunshine ”- by fostering an environment where you grow at every step, take charge of your journey and thrive in a supportive community.\nAre You Ready to Create Your Own Sunshine?\nAs you enter the Sun Pharma world, you’ll find yourself becoming ‘Better every day’ through continuous progress. Exhibit self-drive as you ‘Take charge’ and lead with confidence. Additionally, demonstrate a collaborative spirit, knowing that we ‘Thrive together’ and support each other’s journeys.”\nPosition Summary\nTo provide independent quality review and oversight of CMC development and technology transfer activities, ensuring that development data, processes, and documentation are compliant, scientifically robust, and fit for technology transfer, regulatory submissions and commercial manufacturing readiness.\nKey responsibilities:\nProvide quality oversight for Chemistry, Manufacturing & Controls (CMC) activities within Biotech R&D to ensure compliance with global internal quality standards and regulatory requirements.\nReview and approve CMC development documents, including Product Development Reports, Process Development Reports, Product Quality Risk Assessments, process characterization studies, control strategies, specifications, and regulatory supporting documents.\nConduct independent quality review of upstream and downstream process development data to ensure scientific integrity, completeness, traceability, and compliance with applicable quality requirements.\nSupport technology transfer process by performing quality review and approval of technology transfer protocols, reports, batch records, comparability assessments, and associated technical documentation.\nEnsure data generated during development, scale-up, engineering and submission batches are accurate, complete, and compliant with internal procedures and regulatory expectations.\nReview laboratory notebooks, analytical data packages, development reports, batch manufacturing records, and supporting documentation to verify data integrity and documentation compliance.\nCollaborate with cross functional team to facilitate successful technology transfer and timely resolution of quality-related issues.\nVerify that CMC documents intended for regulatory submissions are scientifically sound, complete, accurate, and inspection-ready.\nDrive implementation and continuous improvement of quality systems, including SOP management, protocol/report lifecycle management, risk management, change control, and stage-gate review processes.\nEnsure development laboratories operate in compliance with internal quality standards, Good Documentation Practices (GDP), data integrity principles, and applicable regulatory expectations.\n\nTravel Estimate\n\nJob Requirements\n\nEducational Qualification\n\n Masters in Biotechnology (M. Tech / MSC) with 8-10 years of experience in biotech development / production / quality assurance\nGood understanding of biologics development, upstream and downstream processing, analytical development, and product lifecycle management.\nKnowledge of global regulatory requirements and guidelines including ICH, GMP, Data Integrity, Quality Risk Management, and regulatory submission requirements for biologics.\nDemonstrated ability to work effectively with cross-functional teams including Process Development, Analytical Development, Manufacturing, Regulatory Affairs, and Quality.\nShall be well versed with various biotech regulations\nShall be having good interpersonal communication and coordination amongst various functions\nExperience of working in quality assurance function is essential\n\nExperience\n\nTenure: 8 to 10 Yrs\n\nYour Success Matters to Us\nAt Sun Pharma, your success and well-being are our top priorities! We provide robust benefits and opportunities to foster personal and professional growth. Join us at Sun Pharma, where every day is an opportunity to grow, collaborate, and make a lasting impact. Let’s create a brighter future together!\n\nDisclaimer: The preceding job description has been designed to indicate the general nature and level of work performed by employee within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees as assigned to this job. Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of incumbent(s).","description_format":"text","description_chars":4668,"description_truncated":false,"requirements":{"experience_years_min":8,"management_years_min":null,"team_size_min":null,"manages_managers":false,"education":{"level":"master","optional":false},"security_clearance":false,"languages":[]},"benefits":[],"hiring_locations":[],"hiring_excludes":[],"relocation_offered":false,"industries":["Biotechnology","Prescription Drugs","OTC & Consumer Health Products","APIs & Drug Manufacturing"],"lifecycle":[{"event":"open","at":"2026-09-29T15:30:21Z"}],"visa":[],"liveness":{"score":60,"band":"ok","label":"Likely open","p_open":1,"p_active":0.802,"p_room":0.75,"age_days":26,"expected_fill_days":30,"reasons":["conf:3","velocity","win:late","comp:brand"],"computed_at":"2026-10-26T05:57:25Z"},"pay":null,"html_url":"https://alion.io/job/sun-pharma-senior-executive-rd-quality-cmc-qa","json_url":"https://alion.io/job/sun-pharma-senior-executive-rd-quality-cmc-qa.json","meta":{"generated_at":"2026-10-26T09:22:57Z","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":12632,"day_limit":null,"remaining_today":null,"minute_limit":300,"resets_at":"2026-10-27T00:00:00Z"}},"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":1808960},"rest":"https://alion.io/mcp/rest/get_company?id=1808960"},"human":"https://alion.io/catalog?offer=company.slices&for=job%2Fsun-pharma-senior-executive-rd-quality-cmc-qa"},{"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%2Fsun-pharma-senior-executive-rd-quality-cmc-qa"},{"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%2Fsun-pharma-senior-executive-rd-quality-cmc-qa"},{"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/sun-pharma-senior-executive-rd-quality-cmc-qa\", \"note\": \"what you need it for\"}"},"human":"https://alion.io/catalog?offer=company.verify&for=job%2Fsun-pharma-senior-executive-rd-quality-cmc-qa"}]}