Abbott
Website:
abbott.com
Job details:
Position : Assistant manager
Section : Analytical Quality Assurance
Qualification : M.Sc. /B. Pharm.
Desirable Experience : 12-14 years
Followings will be the responsibilities of the position holder :
- Quality Management System (QMS) : Must be well-versed in handling QMS systems, including documentation, audits, CAPA, and compliance activities.
- OOS/OOT & Investigations :
Proven experience in managing Out of Specification (OOS) and Out of Trend (OOT) incidents.
Should have handled both Phase-I and Phase-II investigations independently, with thorough documentation and root cause analysis.
- Preferably has worked with Abbott for a minimum of 3 years, demonstrating familiarity with their quality standards and operational procedures.
- To ensure effective implementation of system and procedure as per cGMP, cGLP and other Regulatory requirements, and monitor its compliance.
- To participate in investigation exceptions, market complaints and review the investigation report.
- Practical understanding of HPLC (Empower software) , GC and laboratory instrument handling.
- To act as a laboratory compliance administrator for creation of new users and projects and to review the audit trials.
- Handling of QMS activities (Change Control, Deviations, Exceptions, CAPA, Market complaints, Effectiveness Checks) To ensure the effective implementation of QMS through TrackWise system.
- Ensure Compliance of QMS related SOPs /records.
- To strategize and plan continual improvement in all laboratory activities as per GMP and GLP requirements.
- Review, approval of qualification and Validation documents (URS, DQ, IQ, OQ, PQ etc.)
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