Assistant Manager / Deputy Manager - Quality Control
1 Nos.
149763
Full Time
8.0 Year(s) To 15.0 Year(s)
10.00 LPA TO 15.00 LPA
Production / Quality / Maintenance
M.Sc / MS Science - Chemistry
Job Description:
Key Responsibilities:
- Ensure compliance with cGMP, GLP, FDA and regulatory requirements.
- Lead QC team operations, daily task allocation and technical troubleshooting.
- Review analytical raw data, HPLC/GC audit trails, SOPs and batch release documents.
- Lead investigations related to OOS, OOT, deviations and incidents, including RCA and CAPA.
- Manage stability studies, instrument calibration, analytical method validation/transfer and cleaning verification.
- Maintain reference standards and laboratory documentation.
- Train and guide QC analysts and reviewers.
- Coordinate with QA, Production and Regulatory Affairs for quality-related activities.
- Support regulatory inspections and maintain audit readiness.
Technical Skills:
- Hands-on experience with HPLC, GC, UV-Vis and wet chemistry.
- Strong knowledge of QMS, QRM, GMP and laboratory compliance.
- Working knowledge of SAP Laboratory modules.
- Experience facing USFDA / EDQM / ANVISA audits is mandatory.
- Microbiology knowledge will be an added advantage.
- Good written and verbal English communication skills.
Company Profile
--- --- ---. Ltd. is a 44+ year-old leading active pharmaceutical ingredient (API), an intermediate and chemical manufacturing company. With a solid commitment to excellence and innovation, --- --- has established itself as a trusted partner for businesses across the globe.
We have our head office and an R&D center in Mumbai, India. Two manufacturing sites, one in Roha and another coming up in Saykha, Gujarat. Our sites follow ICH Q7 and GMP guidelines. We are mainly an export-oriented company.
We have been approved by EDQM, PMDA, USFDA, RFDA, KFDA, TFDA, WHO GMP and State GMP.
Apply Now
- Interested candidates are requested to apply for this job.
- Recruiters will evaluate your candidature and will get in touch with you.