Job Description
Job Description
To support Lab - Analytical Quality and compliance is maintained as per the GMP norms
Position / Job Title - Sr. Manager
Department - Quality Assurance – Analytical Lab Quality Assurance
Reporting To - Sr. General Manager – Analytical Lab Quality Assurance
Location - Pithampur
Years of Experience - 12-15 Years
Dosage Form - Solid Oral
Job Responsibilities / Deliverables -
Well versed in the analytical review which includes review of GLP, OOS, OOT, CAPA, Deviation, Incident and Change Control.
Review of analytical documents and electronic records which include worksheet, chromatograms, AMT/AMV, FP/IP/Audit trails/Qualification data of instruments, Analysts.
Preparation of Standard operating procedures and harmonization of the practices.
To review and approve the Certificate of Analysis received from QC for Finished Product. Support batch release activities.
Retention sample management.
Review and ensure compliance of computer system validation as per 21 CFR Part11 and EudraLex Annex11.
Review of stability protocol and reports.
Ensure Laboratory compliance.
Check rounds of lab and internal auditing.
Review of specifications & STP.
Responding to customer communications and queries. Participate in customer and regulatory inspections and ensure CAPA preparedness and effectiveness check.
Leading the group independently in the absence of Manager/Sr. Manager
Qualifications & Pre-Requisites
Must be qualified minimum in B. Pharm/M. Pharm/M.Sc.(Chemistry or relevant)
Must have sound knowledge on handling HPLC, GC, KF, FTNIR, FTIR
Exposure to regulatory audits from various regulatory bodies like US FDA, MHRA, TGA, ANVISA
Exposure to specialized dosage forms such as OSD and nasal formulations is recommended. Knowledge of handling data related to OSD and Nasal is a must.
Team coordination and work distribution
Planning for the team and coordination with functions like QC, Manufacturing, Engineering, Warehouse.
Exposure to microbiology and manufacturing activities are preferred.
Additional Notes
Role is expected to work in all shifts.
Expected to visit Satara, Thane, or other manufacturing sites on need basis and as per business requirements.
