AGM / GM - Maintenance & Project
1 Nos.
154367
Full Time
15.0 Year(s) To 30.0 Year(s)
15.00 LPA TO 30.00 LPA
Production / Quality / Maintenance
B.Pharma - Pharmacy; M.Pharma - Pharmacy
Job Description:
- Lead Production-related QMS activities including SOPs, Deviations, CAPA, Change Control, and Risk Management.
- Lead OOS/OOT investigations with QA/QC and provide technical inputs.
- Review batch records, process parameters, equipment, materials, and manufacturing history.
- Drive root cause analysis, impact assessment, and scientifically justified conclusions.
- Lead investigations for deviations, process failures, batch discrepancies, yield variations, and equipment issues.
- Implement and monitor Production CAPA and ensure timely effectiveness checks.
- Apply investigation tools such as 5-Why, Fishbone, FMEA, and risk assessment.
- Monitor QMS trends and identify opportunities for process and quality improvement.
- Ensure timely closure of Production actions arising from investigations, audits, and QMS activities.
- Support regulatory, customer, corporate, and internal audits and ensure inspection readiness.
- Ensure compliance with cGMP, approved manufacturing processes, validated parameters, SOPs, and safety requirements.
- Drive Good Documentation Practices (GDP) and data integrity across Production operations.
- Ensure proper documentation, review, and compliance of manufacturing records.
- Drive continuous improvement and prevent recurrence of quality and process-related issues.
Key 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.