Senior Executive, Lab QA

• 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.

Additional Responsibilities

Education

• B. Pharm B. Pharm - Required
• M. Pharm M. Pharm - Preferred

Experience

• 5 years or more in 5 - 8 Years

Specialized Knowledge

Licenses