The role
04What you will do:
- Provide QA support to QC functions (clinical and commercial) for GMP compliance-related activities within analytical testing laboratories, including physicochemical and bioassay testing.
- Ensure implementation and adherence to Corporate GMP Quality Manuals and applicable quality standards across Drug Product testing sites.
- Review and approve documentation related to: Analytical method validation Specifications Release testing Stability studies
- Perform review and approval activities in electronic systems such as LIMS, iLab, DMS, and other GMP-relevant platforms.
- Review and approve Change Controls, Deviations, OOS investigations, and CAPAs related to products, processes, and analytical activities.
- Author, review, and approve GMP documents, including SOPs, procedures, gap assessments, and compliance-related tools.
- Support analytical release activities and technical release of drug product batches.
- Participate in and support customer audits, and health authority inspections.
- Promote and enforce compliance with internal policies and external regulations, including GMP requirements, quality standards, and HSE regulations.
- Collaborate with cross-functional stakeholders to drive continuous improvement and maintain a strong quality culture.
01Provide QA support to QC functions (clinical and commercial) for GMP compliance-related activities within analytical testing laboratories, including physicochemical and bioassay testing.
02Ensure implementation and adherence to Corporate GMP Quality Manuals and applicable quality standards across Drug Product testing sites.
03Review and approve documentation related to: Analytical method validation Specifications Release testing Stability studies
04Perform review and approval activities in electronic systems such as LIMS, iLab, DMS, and other GMP-relevant platforms.
05Review and approve Change Controls, Deviations, OOS investigations, and CAPAs related to products, processes, and analytical activities.
06Author, review, and approve GMP documents, including SOPs, procedures, gap assessments, and compliance-related tools.
07Support analytical release activities and technical release of drug product batches.
08Participate in and support customer audits, and health authority inspections.
09Promote and enforce compliance with internal policies and external regulations, including GMP requirements, quality standards, and HSE regulations.
10Collaborate with cross-functional stakeholders to drive continuous improvement and maintain a strong quality culture.
