Batch Record Reviewer (7145)

CTC Resourcing Solutions AG; Wallis; On-site; CHF 62,000 - 96,000; Full time

Job summary

CTC Resourcing Solutions AG and our client seek a Batch Record Reviewer for an on-site 7-month contract in the Valais region of Switzerland. The role focuses on independent review of executed electronic batch records (eBRs) in MES Syncade and ensuring records are complete for QA.

The ideal candidate has GDP/GMP experience in pharma, strong quality focus, excellent communication, and the ability to work under pressure in a collaborative environment.

Qualifications

• Swiss/EU citizenship or valid work permit required.
• Experience in GDP and GMP regulated pharmaceutical / API industry.
• Experience in batch record review (preferred eBR) OR in manufacturing is required.
• Ability to identify non-compliance and gaps from quality standards.
• Very good communication skills and interaction with all kinds of interfaces within the organization; strong team orientation.
• Structured, focused and well-organized working attitude.
• Open-minded for new ideas and suggestions; solution-oriented.
• Agile, highly motivated and dynamic drive.
• Ability to produce reliable results under stress.

Responsibilities

• Perform timely and independent review of executed electronic batch records (eBRs) in MES Syncade.
• Ensures that operations batch records are accurately executed, complete, and ready for QA review.
• Collaborate with Manufacturing and Quality teams to clarify and resolve documentation issues
• Initiate and support in the management of Quality Records (CAPAs and Deviations) for Batch Record review related observations.
• Support preparation of documentation package to enable fast release by QA.

Skills

Batch record review

GDP/GMP experience

eBR experience

Communication skills

Quality compliance

Tools

MES Syncade

Job description

Batch Record Reviewer – 7145

Our client, a global market leader in the production and process support of active pharmaceutical ingredients, both in the chemical and biotechnology sectors, is looking for a Batch Record Reviewer for a contract position for 7 months (with option for extension) in Valais area, Switzerland.

This is an on-site position.

Main Responsibilities:

• Perform timely and independent review of executed electronic batch records (eBRs) in MES Syncade.
• Ensures that operations batch records are accurately executed, complete, and ready for QA review.
• Collaborate with Manufacturing and Quality teams to clarify and resolve documentation issues
• Initiate and support in the management of Quality Records (CAPAs and Deviations) for Batch Record review related observations.
• Support preparation of documentation package to enable fast release by QA.

Qualifications and Experience:

• Relevant working/residency permit or Swiss/EU-Citizenship required
• Previous experience in GDP and GMP regulated pharmaceutical / API industry.
• Experience in batch record review (preferred eBR) OR in manufacturing is required.
• Ability to identify non-compliance and gaps from quality standards.
• Very good communication skills and interaction with all kinds of interfaces within the organization; strong team orientation.
• Structured, focused and well-organized working attitude.
• Open-minded for new ideas and suggestions; solution-oriented.
• Agile, highly motivated and dynamic drive.
• Ability to produce reliable results under stress.