GMP Specialist Documentation & Quality Management (m/f/d) at PS Direkt GmbH & Co. KG (PV)

berlin, Berlin, Germany -

Full Time

Start Date

Immediate

Expiry Date

21 Dec, 26

Salary

90000.0

Posted On

22 Sep, 26

Experience

4 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Industry

Pharmaceutical Manufacturing

Description

Your tasks

You will support the operational team in the production of modern cell therapies.
You carefully check batch records for completeness and GMP compliance.
In case of discrepancies, you coordinate closely with the quality control, quality assurance, and manufacturing departments.
The timely release of batch records is part of your responsibility.
You keep track of processing statuses and documentation processes at all times and ensure a smooth workflow.
In case of errors or discrepancies, you will assist in clarifying the causes and correcting documents.
You independently create, update, and optimize Standard Operating Procedures (SOPs).
You will conduct regular equipment checks according to defined specifications and document them in compliance with GMP.
You actively contribute to the continuous improvement of documentation and quality processes.

Your skills

A completed apprenticeship as a BTA (m/f/d), CTA (m/f/d), biology laboratory assistant (m/f/d), chemistry laboratory assistant (m/f/d) or a comparable qualification
Ideally, initial experience in a GMP-regulated environment or in handling batch records.
Interest in quality assurance, documentation and regulatory requirements
Good written and spoken English skills are an advantage.
Proficient use of MS Office and a passion for precise documentation work.
A structured, meticulous and independent work style
Organizational skills and the ability to set the right priorities
Strong communication skills and enjoyment of collaborating with different departments
A high level of quality awareness and a strong sense of responsibility

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Responsibilities

You will support the operational team in the production of modern cell therapies.
You carefully check batch records for completeness and GMP compliance.
In case of discrepancies, you coordinate closely with the quality control, quality assurance, and manufacturing departments.
The timely release of batch records is part of your responsibility.
You keep track of processing statuses and documentation processes at all times and ensure a smooth workflow.
In case of errors or discrepancies, you will assist in clarifying the causes and correcting documents.
You independently create, update, and optimize Standard Operating Procedures (SOPs).
You will conduct regular equipment checks according to defined specifications and document them in compliance with GMP.
You actively contribute to the continuous improvement of documentation and quality processes.

A completed apprenticeship as a BTA (m/f/d), CTA (m/f/d), biology laboratory assistant (m/f/d), chemistry laboratory assistant (m/f/d) or a comparable qualification
Ideally, initial experience in a GMP-regulated environment or in handling batch records.
Interest in quality assurance, documentation and regulatory requirements
Good written and spoken English skills are an advantage.
Proficient use of MS Office and a passion for precise documentation work.
A structured, meticulous and independent work style
Organizational skills and the ability to set the right priorities
Strong communication skills and enjoyment of collaborating with different departments
A high level of quality awareness and a strong sense of responsibility