Quality Control Lead - cGMP, SAP & Data Integrity

Piramal Pharma Ltd

Barneveld

On-site

EUR 60,000 - 90,000

Full time

23 hours ago

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Job summary

Piramal Pharma Solutions in the Netherlands is seeking a Manager - Quality Control to lead the LIMS master data review and ensure compliant laboratory operations across cGMP standards. You will oversee data entry in SAP, manage analysis planning for finish products and stability samples, and supervise team allocations.

The role requires reviewing OOS/OOT investigations, implementing regulatory updates, conducting internal audits, maintaining QC records, and supporting the Data Integrity

Responsibilities

LIMS Master data review
Entry of data in SAP and release of semi-finished products in SAP
Plan the Analysis of Finish Product and stability samples as per cGMP requirement in time
Allocation of work as per the skills of persons and supervision
Review and approve OOS, OOT and Incident of QC laboratory and carry out OOS investigation
To review and ensure effective implementation of regulatory requirement, guidelines and pharmacopeia changes like IP, BP, USP, Ph. Eur, JP etc.
Review of work output and pending work
To perform self-audit of QC Laboratory on periodic basis
Ensure analysis of Raw Materials / Finished Products as per requirement from Outside Commercial Lab
To check audit trail in QC Instruments
Ensure compliance to KRA’s and other such assignments
To control and maintain QC Laboratory Records. (Like Laboratory note Book, Chromatograms, and COA etc.).
On job training as necessary to develop skills and improve productivity
To ensure cGMP in quality Control laboratory.
Support to site DICO (Data Integrity Compliance Officer) for monitoring and implementation of actions related to Data Integrity awareness at site.

Job description

The role requires reviewing OOS/OOT investigations, implementing regulatory updates, conducting internal audits, maintaining QC records, and supporting the Data Integrity

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