Quality Control Manager
Piramal Pharma Ltd
Barneveld, Gelderland, Netherlands
On-Site
Intermediate
posted 18 days ago
Vacancy Summary
Join Piramal Pharma Solutions as a Quality Control Manager, where you will oversee laboratory operations, ensure compliance with cGMP standards, and manage data integrity. This role offers the chance to work in a globally integrated CDMO environment, contributing to diverse pharmaceutical projects.
Required skills
APIs
Training
Monitoring
Supervision
Audits
Quality Control
analyses
implementation
Analysis
Support
Network
QC
Auditing
Development
LIMS
Regulatory Compliance
Investigations
cGMP
Stability
Data Integrity
Pharma
Forms
Data Entry
SAP
Drug Discovery
In this role, you will be responsible for the review of LIMS master data and ensure the analysis of semi-finished products, stability samples, in-process, and blend samples in accordance with cGMP requirements. You will oversee data entry in SAP and the release of semi-finished products, plan analyses of finished products and stability samples timely, and allocate work based on team members' skills while providing supervision.
Responsibilities
•
Review and approve OOS, OOT, and QC laboratory incidents, conducting OOS investigations as necessary.
•
Ensure effective implementation of regulatory requirements and guidelines, including changes in pharmacopeias such as IP, BP, USP, Ph. Eur, and JP.
•
Perform self-audits of the QC laboratory periodically and ensure compliance with KRA’s and other assignments.
•
Maintain QC laboratory records, including laboratory notebooks, chromatograms, and COAs.
•
Provide on-the-job training to develop skills and enhance productivity.
•
Support the site DICO in monitoring and implementing actions related to data integrity awareness at the site.
About Piramal Pharma Ltd
Piramal Pharma Ltd
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