Senior Executive - Quality Assurance

Piramal Pharma Limited; Mahad; On-site; INR 900,000 - 1,300,000; Full time

Job summary

Piramal Pharma Limited is recruiting for a Senior Executive - Quality Assurance to oversee validation, quality systems, and compliance across the QA functions. The role includes maintaining VMPs, handling process and computer system validations, and coordinating QA documentation and change control processes.

The candidate will participate in self-inspections, CAPA generation, and training as per the training schedule, ensuring alignment with 21 CFR Part 111 regulations for export markets where

Qualifications

• Preparation and updation of Validation Master Plan (VMP).
• Preparation of Process validation and Computer system validation protocol and report.
• Preparation of product matrix and Cleaning Validation/verification protocol and Report.
• Preparation of qualification and requalification protocol and report for processing equipment/instrument, utilities, and facility.
• Preparation of area validation protocol and reports.

Responsibilities

• Sampling of Bulk and Finished goods.
• Review of production records and Finished Goods verification.
• Audit compliance coordination and CAPA responses.
• Prepare and update QA SOPs and load in DCS ENSUR 4.2.

Skills

Validation Master Plan

Process Validation

QA Documentation

GMP Compliance

Tools

DCS ENSUR 4.2

Job description

About the Company

Piramal Pharma Solutions is a contract development and manufacturing organization (CDMO), offering end-to-end development and manufacturing solutions across the drug life cycle. We serve our clients through a globally integrated network of facilities in North America, Europe and Asia. This enables us to offer a comprehensive range of services including Drug Discovery Solutions, Process & Pharmaceutical Development services, Clinical Trial Supplies, Commercial supply of APIs and Finished dosage forms. We also offer specialized services like development and manufacture of Highly Potent APIs and Antibody Drug Conjugation. Our capability as an integrated service provider & experience with various technologies enables us to serve Innovator and Generic companies worldwide. For more details, please visit : www.piramalpharmasolutions.com

Job Title

Senior Executive - Quality Assurance

Job Description

1. Preparation and updation of Validation Master Plan (VMP)
2. Preparation of Process validation, Computer system validation protocol and report.
3. Preparation of product matrix and Cleaning Validation/verification protocol and Report.
4. Preparation of qualification and requalification protocol and report for processing equipment/instrument, utilities, and facility.
5. Preparation of area validation protocol and reports.
6. Preparation and review of quality risk assessments.
7. Batch Record storage, retrieval & destruction.
8. Preparation of APQR.
9. 11.Sampling of Bulk and Finished goods.
10. 9. Review of production records and Finished Goods verification.
11. 10. Online observation of process deviation and effective implementation of CAPA.
12. 11. Management of Change Control / CAPA / Incidences.
13. 12. To coordinate & maintain change control, deviation records.
14. 13. Complaint handling.
15. 14. Preparation and updation of Q.A departmental SOPs and loading it in DCS (Document Control System) ENSUR 4.2
16. 15. To give training as per the Training schedule.
17. 16. To coordinate training program of the company along with HR, including on Job Training.
18. 17. Documentation Management as per SOP.
19. 18. To provide necessary documents / data required by CQA and as per customer’s requirement.
20. 19. Conduct, monitor and review of compliance of Self Inspection Program.
21. 20. Audit compliance coordination, to compile CAPA and prepare response to Audit report in co-ordination with QA Head and technical team.
22. 21. Execution of requirements for food / Dietary supplements regulations for export market (US)-21 CFR Part 111
23. 22. Ensuring avoidance of breach of data integrity in area.
24. 23. Implementation of effective sanitation programme in area.
25. 24. Adherence to the requirements of EHS norms.
26. 25. Execution of various initiatives as are suggested by corporate functions.
27. 26. To determine internal and external QEHS issues as well as needs and expectations of relevant interested parties and monitor the same.
28. 27. To implement QEHS policy & objectives.
29. 28. To ensure participation and consultation of worker.
30. 29. Ensure use of PPE
31. 30. To identify & communicate incidents, QEHS nonconformities, investigate and take corrective actions on the same.
32. 31. To ensure work permit system during maintenance activities.
33. 32. To implement QEHS continual improvement projects at site and monitor.
34. 33. Authorized to prevent improper workplace conditions.
35. 34. Authorised for reporting of Hazards, Incident, Accidents and Near miss reporting.
36. 35. Authorised to prepare OH&S performance document.
37. 36. Authorised to conduct training of workmen related to OHSMS.
38. 37. Planning / Scheduling & execution of Vendor Audits of Raw Material, Excipient & Packaging Material.
39. 38. Maintenance, Approval & deletion of MPN linkage with co-ordination with SCM, CQA & MDM team.
40. 39. Maintenance of Approved vendor list for Raw & Packaging materials.
41. 40. Review of Vendor Performance monitoring record.

Piramal Pharma Limited, offers a portfolio of differentiated products and services through its 17 global development and manufacturing facilities and a global distribution network in over 100 countries. PPL includes Piramal Pharma Solutions (PPS), an integrated Contract Development and Manufacturing Organization; Piramal Critical Care (PCC), a Complex Hospital Generics business; and the India Consumer Healthcare business, selling over-the- counter products. In addition, one of PPL’s associate companies, AbbVie Therapeutics India Private Limited is a JV with AbbVie Inc. and has emerged as one of the market leaders in the ophthalmology therapy area. Further, PPL has a minority investment in Yapan Bio Private Limited. In October 2020, PPL received a 20% strategic growth investment from the Carlyle Group.

PPL provides equal employment opportunities to all employees and applicants for employment. It prohibits discrimination and harassment based on race, color, age, sex, religion, national origin or ethnicity, disability status, genetics, protected veteran status, sexual orientation, gender identity, or expression, or any other characteristic protected by applicable law. Our employment decisions are based on merit considering qualifications, skills, performance, and achievements. Equal employment opportunity applies to all terms and conditions of employment, including recruitment, selection, training, social programs, placement, promotion, demotion, compensation and benefits, transfers, terminations, and working conditions.