Senior Executive-QA

Piramal Pharma Limited; Mahad; On-site; INR 600,000 - 800,000; Full time

Job summary

Piramal Pharma Limited is seeking a Senior Executive-QA to oversee quality assurance activities in manufacturing, packing and dispensing. The role involves line clearance, in-process checks, and strict adherence to GMP and data integrity norms. The successful candidate will ensure accurate batch records review and CAPA implementation, with on-the-job training for production staff.

The position requires B. Pharm or M.

Qualifications

• B. Pharm or M. Pharm (full time) required.
• Relevant QA experience in pharmaceutical manufacturing and quality assurance is beneficial.
• Knowledge of GMP, regulatory guidelines and CAPA processes preferred.

Responsibilities

• Area and line clearance for Manufacturing, Packing & Dispensing activities.
• Inprocess checks in Manufacturing and Packing activities.
• Inspection of dispensing activity and online batch records.
• Daily verification of balance calibration and environmental monitoring.
• Verification of equipment and area cleanliness during line clearance.
• Review of production records and finished goods verification.
• On-job training to new production personnel and adherence to EHS norms.
• Audit compliance, qualification and validation activities.

Education

B. Pharm or M. Pharm

Job description

Senior Executive-QAExecutive Quality AssuranceJob Description

• 1. Area and line clearance for Manufacturing, Packing & Dispensing activity in production area.
• 2. Inprocess checks in Manufacturing and Packing activity.
• 3. Inspection of dispensing activity intermediately.
• 4. Daily verification of weighing balance calibration activity.
• 5. Daily verification of environmental monitoring of raw material staging area and Manufacturing and Packing area.
• 6. Verification of each equipment cleanliness and area cleanliness during line clearance
• 7. Verification and review of online Batch Manufacturing Records.
• 8. Sampling of bulk stage and finished goods analysis and control sample.
• 9. Verification of production documents.
• 10. Daily non conformance observation reported and maintained.
• 11. In process quality checks in Tablet, Liquid, HNH, ANH manufacturing dept.
• 12. Line Clearance for Manufacturing, Packing & Dispensing activity.
• 13. Sampling of Bulk and Finished goods
• 14. Review of production records and Finished Goods verification
• 15. On job training to the new people working in the production area.
• 16. Statistical Process Monitoring.
• 17. Online observation of process deviation and effective implementation of CAPA.
• 18. Reporting of daily non conformance.
• 19. Execution of requirements for food/Dietary supplements regulations for export market (US)-21 CFR Part 111
• 20. Ensuring avoidance of breach of data integrity in area.
• 21. Implementation of effective sanitation program in area.
• 22. Imparting required training to shop floor personnel.
• 23. Adherence to the requirements of EHS norms.
• 24. Audit compliance, Qualification and validation activities

Essential Qualification

B. Pharm or M. PharmFull time

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.