Salary Range: ₹10 to ₹12 LPA (Negotiable for the right candidate)
Joining: Immediate to 30 Days Preferred
About the Role:
We are looking for an experienced and detail-oriented Assistant Quality Manager to join our Quality Assurance department in a fast-growing and reputed pharmaceutical manufacturing company based in SIDCUL, Pantnagar.
The ideal candidate must have a strong understanding of GMP, ICH guidelines, regulatory documentation, audits, validations, and pharmaceutical QA systems. This is a leadership-level role responsible for maintaining and improving the quality system across departments and ensuring compliance with national and international standards.
Key Responsibilities:
Supervise and ensure compliance with GMP (Good Manufacturing Practices) and regulatory requirements
Manage and oversee the documentation system: SOPs, BMRs, protocols, deviations, CAPA, change control, etc.
Coordinate and assist in regulatory audits – USFDA, MHRA, WHO-GMP, CDSCO, etc.
Monitor and lead the implementation of Quality Management Systems (QMS)
Handle product and process validation, equipment qualification, and cleaning validation activities
Review and approve specifications, protocols, and analytical reports
Ensure timely investigation and closure of deviations, market complaints, and OOS/OOT reports
Lead and train a team of quality professionals in cGMP compliance and documentation
Actively participate in internal and external audits and contribute to continual improvement
Collaborate with R&D, Production, QC, and Regulatory departments for alignment of QA activities
Qualification & Experience:
Educational Qualification:
B.Pharm / M.Pharm / M.Sc. in Chemistry or related field (Must)
Experience Required:
Minimum 8–10 years of relevant experience in Quality Assurance in a regulated pharmaceutical manufacturing unit
Exposure to formulations (oral solids/liquids/injectables) preferred
Sound knowledge of:
GMP, ICH, and regulatory guidelines
Quality systems (QMS, CAPA, Risk Assessment, Change Control)
Regulatory bodies like USFDA, WHO, MHRA, etc.
Required Skills:
Strong leadership and team management skills
Proficient in documentation and audit handling
Excellent verbal and written communication
Ability to work under pressure and meet deadlines
Good command over MS Office and electronic documentation systems
Interested candidate share your resume at: Bdsjobconsultants@gmail.com
Contact HR at: 7830699111
www.bdsbharatjobs.com
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