About the role

The Senior Executive - QA is responsible for reviewing analytical raw data, audit trails, and laboratory documentation to ensure compliance with GMP/GxP standards. They will also manage QMS events such as OOS, OOT, deviations, and incidents while overseeing the maintenance of analytical SOPs.

What they look for

Quality Assurance GMP GxP QMS Analytical Data Review HPLC GC-MS ICPMS LC-MS XRPD SOP Development Audit Trails OOS Investigation Deviation Management Analytical Method Validation Computer System Validation

Requirements

Candidates must have a strong background in analytical quality assurance and experience with laboratory instruments like HPLC, GC-MS, and LC-MS. Proficiency in reviewing analytical protocols, validation reports, and maintaining quality compliance within a pharmaceutical environment is required.

Full description

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Division

Piramal 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.com

Job Title

Senior Executive - QAJob 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.