Senior Executive - QA

Piramal Pharma; Ahmedabad District; On-site; INR 600,000 - 900,000; Full time

Job summary

Piramal Pharma Solutions is a contract development and manufacturing organization providing end-to-end services for drug substances and products. A Senior Executive - QA is needed to ensure laboratory GMP/GxP compliance and to review analytical data and audit trails from instruments.

You will investigate QMS events (OOS, OOT, deviations), review analytical SOPs and validation reports, and prepare quality documentation to support continual improvement across analytical operations.

Qualifications

• Review analytical raw data and audit trails to ensure data integrity.
• Investigate QMS events including OOS, OOT and deviations.
• Review and approve analytical SOPs and quality documents for compliance.

Responsibilities

• Review analytical raw data and documents.
• Review electronic data and audit trails for instruments such as HPLC, GC-MS, ICP-MS, LC-MS, XRPD.
• Monitor laboratory compliance as per GMP/GxP procedures.
• Investigate QMS events (OOS, Deviation, Incident, OOE, OOT).
• Review and approve analytical method validation/verification, transfer protocols and reports.

Skills

Analytical QA

GxP compliance

Audit trails

Instrument data review

HPLC

GC-MS

LC-MS

XRPD

Tools

HPLC

GC-MS

ICP-MS

LC-MS

XRPD

Job description

Be the First to ApplyDivisionPiramal Pharma SolutionsPiramal 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.comJob TitleSenior Executive - QAJob DescriptionPersonnel 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 improvementReview 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.