Senior Quality Control Officer

Job Title:Senior Quality Control Officer

Job Location:Ankleshwar, Gujarat

Industry:API / Pharma / Chemical Manufacturing

Experience Range:3 to 6 years in Quality Control within an API manufacturing company

Qualifications & Required Skills:

M.Sc. or B.Sc. in a relevant field

Experience in Quality Control within an API plant

Expertise in HPLC calibration

Hands-on experience with HPLC and Gas Chromatography (GC)

About the Company:

A well-established corporate group with over 50 years of industry experience

A leading Indian manufacturer of pharmaceutical excipients, active pharmaceutical ingredients (APIs), and specialty chemicals

Headquartered in Mumbai, with manufacturing plants in Gujarat and Maharashtra

Global operations spanning North America, Europe, Asia, Africa, and South America

Job Responsibilities:

1. Conduct analysis using HPLC and Gas Chromatography as per testing methods and pharmacopeia monographs.
2. Perform scheduled calibration of HPLC and Gas Chromatography instruments.
3. Troubleshoot issues related to HPLC and Gas Chromatography.
4. Investigate out-of-calibration occurrences for HPLC and Gas Chromatography.
5. Assist the Head of QC in investigating Out-of-Specification (OOS) results.
6. Review audit trails for HPLC and Gas Chromatography.
7. Ensure compliance with 21 CFR electronic signature requirements.
8. Oversee Quality Management System (QMS) activities, including change control, deviations, Out-of-Control (OOC), and OOS cases.
9. Conduct analysis of raw materials, in-process samples, equipment cleaning verification, vendor qualification, and finished product samples with accuracy and timeliness.
10. Prepare specifications and methods of analysis based on pharmacopeia or customer requirements.
11. Develop and maintain Standard Operating Procedures (SOPs).
12. Prepare standard solutions, reagents, and volumetric solutions.
13. Manage stability sample charging and analysis as per schedule.
14. Maintain glassware, chemicals, and reagent stock for regular use.
15. Arrange, segregate, and store chemicals as per SOP guidelines.
16. Ensure adherence to safety protocols in the laboratory.
17. Participate in on-the-job training and periodic training programs.
18. Follow company HR policies, including attendance and discipline.
19. Uphold the company's quality policy.
20. Foster teamwork to support company growth.
21. Provide documentation and support during internal audits, customer audits, and regulatory inspections.
22. Ensure compliance with GMP/GLP standards within the company premises.
23. Ensure proper usage of Personal Protective Equipment (PPE) where required.
24. Control waste generation and prevent reagent and chemical spillage during analysis.
25. Perform any additional tasks assigned by the department head.