Deputy Manager - QA
- Piramal Pharma Limited
- 9 - 14 years
- Hyderabad
- 2 days ago
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Job Description
The Deputy Manager - Quality Management System (QMS) is responsible for overseeing and ensuring the effective implementation, maintenance, and improvement of the Quality Management System within the PCC Digwal. The role involves meticulous management of documentation, adherence to regulatory requirements, and proactive involvement in quality-related processes.
Key Responsibilities:
Key Responsibilities:
1. Manage the ENSUR system for issuance and retrieval of SOPs, specifications, ATRA, worksheets, stability protocols, BMRs, BPRs, BFRs, etc., as per requirements.
2. Ensure adherence to document control procedures, including archival, retention, and destruction of documents as defined in the procedure.
3. Manage master and obsolete copies of SOPs, specifications, ATRs, worksheets, stability protocols, BMRs, BFRs, BPRs, etc.
4. Track SOPs, procedures, specifications, etc., for revision according to their validity period.
5. Responsible for archival management, including archival and retrieval of documents as required.
6. Perform login and review of quality management system documents such as change controls, CAPA management, OOS, OOT, deviations, incidents, complaints, OOC, etc.
7. Track all quality management system documents till closure, including change controls, CAPA management, OOS, OOT, deviations, incidents, complaints, OOC, etc.
8. Generate monthly tracking reports for quality management systems as per defined procedures.
9. Handle product quality complaints (Adverse Events) and medical inquiry reconciliation tracker for the Digwal site, coordinating with Pharmacovigilance team for adverse events as applicable.
10. Review and approve investigation reports, risk assessment reports, and ensure the implementation and effectiveness assessment of CAPAs.
11. Review quality system documents such as protocols, reports, procedures, APOR, trend analysis reports, continual process verification reports, etc., as required.
12. Share documents with the Regulatory Affairs department for filing updates based on change control implementation.
13. Prepare and review customer and external audit compliance reports.
14. Review and approve analytical reports such as batch analysis, standards, stability studies, etc.
15. Perform GMP verification and compliance review.
16. Ensure compliance with Safety, Health, and Environment (SHE) guidelines, rules, and regulations, including the usage of Personal Protective Equipment (PPE) where applicable.
Qualifications:
- Bachelors degree in pharmacy, Chemistry, or related field. Master's degree preferred.
- 8-12 years of relevant experience in pharmaceutical Quality Assurance/QMS roles( API / API & Formulations )
- Strong understanding of regulatory requirements and quality standards in the pharmaceutical industry.
- Excellent organizational, communication, and problem-solving skills.
Ability to work effectively in a team and independently, with attention to detail and accuracy
Skills:
- Proficiency in handling documentation and data management systems, particularly Harmony.
- Strong organizational skills with attention to detail and the ability to manage multiple priorities.
Job Classification
Industry: Pharmaceutical & Life SciencesFunctional Area / Department: Quality AssuranceRole Category: Quality Assurance - OtherRole: Quality Assurance - OtherEmployement Type: Full timeContact Details:
Company: Piramal Pharma LimitedLocation(s): Hyderabad
Keyskills: GMP CAPA QMS BPR BMR Documentation BFR USFDA Change Control Investigation RM Deviation Quality Assurance PM
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