Senior Executive, Lab QA
Amneal Pharmaceuticals
- Review analytical data for Raw Materials (RM), Packaging Materials (PM), in-process samples, Finished Products (FP), stability samples, working standards, reference standards, and other test samples.
- Review and approve Certificates of Analysis (COAs) for RM, PM, in-process samples, FP, stability working standards, reference standards, and other test samples. samples.
- Review SOPs, STPs, specifications, and other laboratory documents.
- Verify the accuracy of data entered in LIMS and manual documentation systems.
- Review protocols and reports related to analytical method transfer, validation, verification, and waiver activities. Review analytical raw data associated with method transfer, validation, and verification studies.
- Review and approve daily verification, calibration, and qualification records of laboratory instruments and equipment.
- Review and approve Computer System Validation (CSV) documents.
- Review instrument logbooks, calibration records, and third-party calibration reports.
- Review and approve the audit trail reports for Empower and non-CDS systems.
- Review stability schedules, stability protocols and stability reports.
- Ensure data integrity and compliance with ALCOA principles and documentation practices. Verify analytical records for compliance with GLP and cGMP requirements.
- Review investigations related raw data and report i.e. OOS, OOAL/OOT, deviations, incidents, and change controls.
- Review vendor qualification reports and related documentation.
- Review reduced testing reports and related documentation.
- Review analytical data and COAs received from contract testing laboratories.
- Review and approve preparation records of reagents, mobile phases, diluents, impurity solutions, and other laboratory solutions.
- Review analytical raw data for analyst qualification and approved.
- Verify compliance of laboratory activities through documentation review.
QUALIFICATIONS
Education
- B. Pharm B. Pharm - Required
- M. Pharm M. Pharm - Preferred
- 5 years or more in 5 - 8 Years