Quality Specialist (m/f/d) | Batch Record Reviewer Pharm at Gi Group Deutschland GmbH

berlin, Berlin, Germany -

Full Time

Start Date

Immediate

Expiry Date

28 Dec, 26

Salary

90000.0

Posted On

29 Sep, 26

Experience

4 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Industry

Pharmaceutical Manufacturing

Description

Your tasks as a Quality Specialist (m/f/d)

Checking batch records and related documentation for completeness and accuracy
Review of manufacturing protocols in the field of sterile or aseptically manufactured products
Ensuring GMP-compliant documentation and adherence to relevant SOPs and process specifications.
Assistance in preparing batch release by the Qualified Person (QP)
Creation and editing of documents in a GMP-regulated environment
Document storage and archiving of quality-relevant documents
Support with qualification and validation activities
Assistance with the introduction of new products
Preparation and support for internal and external audits and inspections
Collaboration with related areas such as production, quality control and quality assurance

Your profile as a Quality Specialist (m/f/d)

Completed training in the pharmaceutical, chemical or scientific field
Professional experience in the pharmaceutical industry, ideally in a GMP-regulated production environment
Experience in batch record review, preferably in the area of aseptic filling and optical inspection
Willingness to work in a Class D cleanroom
A good understanding of pharmaceutical production and sterilization processes
Experience in handling manufacturing and production-related documentation
Good knowledge of national and international cGMP requirements, especially EU-GMP and FDA regulations.
Excellent knowledge of SAP
Experience with document management systems such as QualiPSO is an advantage.
Fluent German skills; English skills are an advantage.
Careful, structured and quality-oriented work methods
Organizational skills and the ability to prioritize even under heavy workloads.
Teamwork skills and enjoyment of working together in interdisciplinary teams

Responsibilities

Checking batch records and related documentation for completeness and accuracy
Review of manufacturing protocols in the field of sterile or aseptically manufactured products
Ensuring GMP-compliant documentation and adherence to relevant SOPs and process specifications.
Assistance in preparing batch release by the Qualified Person (QP)
Creation and editing of documents in a GMP-regulated environment
Document storage and archiving of quality-relevant documents
Support with qualification and validation activities
Assistance with the introduction of new products
Preparation and support for internal and external audits and inspections
Collaboration with related areas such as production, quality control and quality assurance

Completed training in the pharmaceutical, chemical or scientific field
Professional experience in the pharmaceutical industry, ideally in a GMP-regulated production environment
Experience in batch record review, preferably in the area of aseptic filling and optical inspection
Willingness to work in a Class D cleanroom
A good understanding of pharmaceutical production and sterilization processes
Experience in handling manufacturing and production-related documentation
Good knowledge of national and international cGMP requirements, especially EU-GMP and FDA regulations.
Excellent knowledge of SAP
Experience with document management systems such as QualiPSO is an advantage.
Fluent German skills; English skills are an advantage.
Careful, structured and quality-oriented work methods
Organizational skills and the ability to prioritize even under heavy workloads.
Teamwork skills and enjoyment of working together in interdisciplinary teams