Executive/Asst. Manager - QA(P)

Executive/Asst. Manager - QA(P)

2 Nos.
116047
Full Time
7.0 Year(s) To 15.0 Year(s)
9.00 LPA TO 12.00 LPA
Production / Quality / Maintenance
Pharma/Biotech/Clinical Research
B.Pharma - Pharmacy; M.Pharma - Pharmacy
Job Description:

Position:           Executive/Asst. Manager - QA

Location:          Pariya - Vapi

Experience:      7 - 15 Years

Industries:       Pharma

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

Salary :- Upto 12.00 LPA

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: -

Key Skills :
Company Profile

Leading API Manufacturing USFDA Approved Company located at Vapi

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