Quality - Compliance Analyst

View: 172

Update day: 25-04-2024

Location: Schaffhausen Schaffhausen SH

Category: Legal / Contracts

Industry: Staffing Recruiting

Position: Associate

Job type: Full-time

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Job content

For our client, we are currently looking for a Quality/Compliance Analyst to join their team in Schaffhausen.General Information

Your Responsibilities

Timely processing/closing of non-conformances (quality issues)
Timely checking and final assessment of master data (parts lists, manufacturing instructions, Q-relevant material master data, DMD/AGG, etc.)
Timely processing of batch splits and reworking including making the usage decisions for batches
Review and approval of SOPs and operating instructions
Assessor & Approver for CoCs
QA-side support for other departments on GMP compliance issues
Comply with the GMP, SHE, and SOX requirements and guidelines associated with the respective function.
Management and documentation of non-conformances
Review & approval of Q-relevant master data, BOM, recipes, DMD/AGG codes, etc.
Execution of batch splits and supervision of reworking including making the usage decisions for batches
Key contact for production, logistics, regulatory affairs and external customers
Review & Approval of product-specific SOPs, WIs, etc.
Membership in working and project groups as required and assigned

Your Profile

A minimum of a Bachelor’s Degree (MSc desired) in a scientific field
2-3 years of experience and already experience in the pharmaceutical sector (GxP)
Ability to perform "hands-on" troubleshooting and problem-solving.
Good technical understanding of manufacturing equipment and processes desired
A thorough understanding of GMP/ISO regulations and validation regulations is preferred.
Business Fluent in German and English is required

Have we sparked your interest? Then, I look forward to receiving your application today.

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