Executive/Asst. Manager - QA(P)

Responsibilities:

• Monitor manufacturing and packaging processes, including line clearance and in-process checks (IPQA)
• Manage documentation activities, including DOC-QMS systems, SOP preparation, deviation handling, and change control
• Support Technology Transfer (TT) activities by reviewing protocols, executing processes, and coordinating between R&D and manufacturing teams
• Ensure compliance with 21 CFR Part 11 requirements through validated software systems for electronic records and signatures
• Execute equipment qualification (DQ, IQ, OQ, PQ), process validation, and cleaning validation activities
• Utilize automated quality systems and digital platforms for manufacturing documentation
• Maintain and manage electronic Batch Manufacturing Records (E-BMR) and Logbooks for real-time documentation and traceability
• Implement and maintain Quality Management Systems (QMS) in line with regulatory standards
• Conduct and document risk assessments for processes, equipment, and product quality
• Coordinate and face regulatory audits, manage CAPAs, and ensure timely closure
• Provide leadership, effective communication, and cross-functional coordination across teams

Required skills:

• Team management and cross-functional coordination
• Experience in conducting internal and vendor audits with corrective action planning
• Regulatory knowledge and ability to handle various audits
• Strong analytical and troubleshooting skills
• Capability to supervise and mentor production officers, operators, and technical staff
• Ability to conduct training sessions on SOPs, safety protocols, and software usage
• Commitment to fostering a culture of continuous improvement and operational excellence

Required Qualification: - B.Pharm/M.Pharm

If you are interested in this opening, please send updated resume on same mail with following details.

Total No. of Years Experience: -

Current CTC: -

Expected CTC: -

Notice Period: -