Executive/Asst. Manager - QC

Job Description:

Position:           Executive/Asst. Manager - QC

Location:          Vapi

Experience:      5 - 12 Years

Industries:       Pharma

Responsibilities:

• Analytical Operations:
• Perform and supervise analysis of Raw Materials (RM), Packing Materials (PM), and Finished Goods (FG).
• Operate and maintain analytical instruments:- HPLC, GC, UV-Vis, FTIR, Dissolution Apparatus
• Ensure compliance with GLP, 21 CFR Part 11, and data integrity standards.
• Review and approve analytical reports and LIMS entries , Quality Systems & Compliance
• Implement and monitor Quality Management Systems (QMS).
• Lead investigations for OOS, OOT, Deviations, and Laboratory Incidents.
• Prepare and review SOPs, STPs, and validation protocols.
• Ensure audit readiness and support regulatory inspections (USFDA, WHO-GMP, etc.) Documentation & Reporting
• Maintain accurate documentation in LIMS and ensure traceability.
• Prepare investigation reports, CAPA, and trend analysis.
• Coordinate with cross-functional teams for timely release and compliance ,Project & Team Leadership
• Mentor and train QC analysts on instrumentation and regulatory practices.
• Lead or contribute to method validation, tech transfer, and stability studies.
• Drive continuous improvement initiatives and lean lab practices.

Required skills:

• Strong command of 21 CFR Part 11, GLP, and GMP guidelines.
• Proficiency in LIMS and electronic documentation systems.
• Expertise in handling OOS/OOT investigations and CAPA implementation.
• Experience in regulatory audits, data integrity, and instrument calibration.
• Knowledge of ICH guidelines, method development, and stability protocols Preferred Attributes.
• FDA-approved analyst (preferred).
• Experience in handling project work related to analytical method development or tech transfer.
• Excellent communication, leadership, and problem-solving skills.

Required Qualification: - B.Sc/M.Sc - Chemistry/Microbiology/Biotechnology

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: -