Senior Executive-QC

Piramal Pharma Ltd; Barneveld; On-site; EUR 42,000 - 62,000; Full time

Job summary

Piramal Pharma Solutions in Barneveld is seeking a Senior Executive-QC to perform stability and finished product analysis, ensuring cGMP adherence and maintaining comprehensive laboratory records. You will prepare and standardize volumetric solutions and reagents, document results, and report any deviations promptly.

Role includes data integrity support, vendor sample review and ensuring the laboratory operates under GLP/GMP requirements. On-site role in the Netherlands with potential for growth.

Qualifications

• Analysis of stability and finished product samples per cGMP.
• Receipt, storage of QC samples and disposition after analysis.
• Preparation and standardization of volumetric solutions and reagents.
• Concurrent documentation of analytical records and data storage.
• Immediate reporting of deviations, OOT or OOS to Head QC.
• Procurement of chemicals, reagents and standards for new projects.
• Maintenance of chemical store bin cards.
• Implementation of GLP/GMP requirements.
• Allocate work to workers and train them.
• Maintain QC laboratory records and review chemicals.
• Analyze vendor approval samples and support Data Integrity.

Responsibilities

• Analysis of stability and finished product samples.
• Ensure cGMP compliance in all QC activities.
• Document analytical records and maintain data integrity.
• Prepare reagents and maintain laboratory inventory.
• Report deviations and participate in GLP/GMP adherence.

Skills

Quality control

cGMP compliance

GLP

Documentation

Tools

GC

Dissolution

UV

Job description

Be the First to Apply

Division

Piramal Pharma Solutions

Piramal Pharma Solutions is a contract development and manufacturing organization (CDMO), offering end-to-end development and manufacturing solutions across the drug life cycle. We serve our clients through a globally integrated network of facilities in North America, Europe and Asia.

This enables us to offer a comprehensive range of services including Drug Discovery Solutions, Process & Pharmaceutical Development services, Clinical Trial Supplies, Commercial supply of APIs and Finished dosage forms. We also offer specialized services like development and manufacture of Highly Potent APIs and Antibody Drug Conjugation.

Our capability as an integrated service provider & experience with various technologies enables us to serve Innovator and Generic companies worldwide.

For more details, please visit : www.piramalpharmasolutions.com

Job Title

Senior Executive-QC

Job Description

Analysis of Stability and Finish product samples.

• Analysis of Finished products, Raw Materials, stability and related documentation as per cGMP.
• Receipt/Inward/Storage of QC samples and Disposition of sample after analysis.
• Preparation and Standardization of volumetric solutions/ Reagents/ Indicator solution preparation as and when required.
• Concurrent documentation of analytical records and storage of raw data, Online entries in Instrument/ Equipments usage log books.
• Instant reporting in case of any deviation, incident, OOT or OOS to Section Head/ Head QC.
• Requirement / Procurement of chemical/ reagents/ standards/ columns required for new project.
• Any additional responsibility assigned by section head.
• Maintenance of Bin Card of chemical store.
• Implementation of GLP / GMP requirements.

10 Allocate works to workmen and trained them.

• To control and maintain QC Laboratory Records. (Like Laboratory note Book, Chromatograms, and COA etc.).
• Analysis of Vendor Approval samples.
• Review of laboratory chemicals.
• Responsible for only run the method in the GC, Dissolution & UV does not access to Change the method, report format, cancellation of any run, or system and method configuration.
• Support to site DICO (Data Integrity Compliance Officer) for monitoring and implementation of actions related to Data Integrity awareness at site.