Senior Executive - QA

Piramal Pharma Ltd; Ahmedabad District; On-site; INR 600,000 - 1,000,000; Full time

Job summary

Piramal Pharma Solutions in Ahmedabad invites Senior Executive - QA to join its analytical QA team. You will review analytical raw data, electronic data and audit trails for laboratory instruments, ensure GMP/GxP compliance, and support continual improvement.

Responsibilities include investigating QMS events (OOS, OOT, OOE, deviations, incidents), reviewing and maintaining analytical SOPs and quality documents, and training subordinates on GxP standards.

Qualifications

• Analytical QA background with GMP/GxP experience.
• Ability to review analytical raw data, electronic data and audit trails.

Responsibilities

• Carry out activities of Analytical QA personnel.
• Review analytical raw data and documents.
• Review electronic data and audit trails for instruments (HPLC, GC-MS, ICPMS, LC-MS, XRPD).
• Monitor compliance in the laboratory per procedures.
• Investigate QMS events including OOS, Deviation, Incident, OOT, OOE.
• Review Analytical SOPs for compliance and continual improvement.
• Review and approve analytical documents like specifications, test procedures, validation/verification protocols and reports, transfer protocols and reports, stability reports, investigation reports, trend reports.
• Review and approve raw material, packing material, and finished product analytical data.
• Review Product development reports.
• Review computer system validation documents.
• Prepare SOPs related to QA Department.
• Periodically review analytical records (instrument logs, calibration records, standard management records).
• Impart induction training on topics covered by training.
• Follow GxP (GMP, GDP) for all processes and train subordinates to follow.

Job description

Division

Piramal Pharma Solutions

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 - QA

Job Description

Personnel with Analytical QA background. Review analytical raw data, electronic data, and audit trails for laboratory instruments. Ensure laboratory compliance with GMP/GxP requirements and established procedures. Investigate and manage QMS events- including OOS, OOT, OOE, deviations, and incidents. Review, approve, and maintain analytical SOPs and quality documents for continual improvement.

• To carry out activities of Analytical QA personnel.
• Review of analytical raw data and documents.
• Review of electronic data and audit trail for instruments like HPLC, GC-MS, ICPMS, LC-MS, XRPD.
• Monitoring compliance in laboratory as per laid down procedures.
• Investigation of QMS – OOS, Deviation, Incident, OOT, OOE.
• Review of Analytical SOPs for compliance requirements and continual improvement
• Review and approval of analytical documents such as specifications, test procedures, analytical method validation / verification protocols & reports, Analytical method transfer protocols & reports, stability reports, investigation reports, trend reports etc.
• Review and approve the raw material, packing material, finished product analytical data.
• Review of Product development reports.
• Review of computer system validation documents.
• Prepare SOPs related to QA Department.
• Periodic review of analytical records (instrument logbooks, calibration records, standard management records etc.)
• Impart induction training on topics and on which training has been taken.
• Follow GxP (GMP, GDP etc.) for all processes and train the subordinates to follow the same.