Job description:

Roles and Responsibilities:

- Documents review pertaining periodical/change revisions of SOPs, MFRs, BMRs, CFT documents etc.

- Responsible for Change controls and Deviations to closure as per timelines.

- Responsible review and approval of APQR and CPVR.

- Responsible review and approval of Process Validation and Cleaning Validation documents.

- Responsible for IPQA functions.

- Ensuring all general Incidents are completed in time or justified with Risk Assessments.

- Planning and Execution of Internal Audits and ensuring compliance.

- Review and Approval of Equipment / Facility Qualification documents.

- Documentation Control.

- Conducting of Trainings as when required.

- Handling of Vendor Qualification activities i.e., Vendor audits, audit report, ensuring compliance and audit closure report.

- Review and Approval of R&D documents i.e., Use test reports, Development reports, Lab Validation documents etc.

- Follow code of conduct and adhere to discipline, integrity and policies & procedures

- Maintain confidentiality & non - disclosure as per the applicability

- Maintain the work place clean, orderly and place all the items at designated places

- Fill all the documents in contemporaneous, legible & accurate manner

- Check documents of others for contemporaneous, legibility & accuracy as applicable

- Adhere to PPE, safety precautions as applicable

- Check adherence of others to PPE, safety precautions as applicable

- Report potential hazards / near misses / accidents to the relevant personnel

- Attend to emergency handling trainings and follow as required

- Follow MSDS before handling any material

- Handle the tasks of colleagues / superiors in their absence as applicable

- Handle the tasks as assigned by your reporting Manager from time to time.