QA Specialist Batch Release (m/w/d)

Responsibilities:

Creation and adaptation of documents, inspection plans, and CoA profiles.

Coordination of the review of manufacturing documents and timely processing of batch documentation for biological products

Communication with the specialist departments at the site to obtain corrections, deviations, missing documentation and their evaluation.

Communication with the contract manufacturer to obtain corrections, deviations, missing documentation and their evaluation

Preparation of the release-relevant, country-specific GMP documentation

Adaptation to current regulations of the respective country

Creation and review of GMP-relevant documents (e.g., SOPs, SAP test plans)

Independent communication in local/global meetings and teleconferences for the introduction of new biological products

Collection of batch-related data for tracking and trending / Data Warehouse

GMP-compliant archiving of documents (e.g. in Rims or OneVault)

Requirements:

Completed commercial, scientific, technical or pharmaceutical training

At least 2 years of experience in a pharmaceutical environment, quality assurance experience preferred.

Strong understanding of GMP

Strong quality awareness

Fluent in German and English, both spoken and written.

IT skills in MS Office, SAP

Good prioritization skills

Good teamwork skills and cooperation with colleagues and superiors

Solution-oriented thinking

Independent work style and ability to independently familiarize oneself with workflows and processes.

QA Specialist Batch Release (m/w/d)

Responsibilities:

Creation and adaptation of documents, inspection plans, and CoA profiles.

Coordination of the review of manufacturing documents and timely processing of batch documentation for biological products

Communication with the specialist departments at the site to obtain corrections, deviations, missing documentation and their evaluation.

Communication with the contract manufacturer to obtain corrections, deviations, missing documentation and their evaluation

Preparation of the release-relevant, country-specific GMP documentation

Adaptation to current regulations of the respective country

Creation and review of GMP-relevant documents (e.g., SOPs, SAP test plans)

Independent communication in local/global meetings and teleconferences for the introduction of new biological products

Collection of batch-related data for tracking and trending / Data Warehouse

GMP-compliant archiving of documents (e.g. in Rims or OneVault)

Requirements:

Completed commercial, scientific, technical or pharmaceutical training

At least 2 years of experience in a pharmaceutical environment, quality assurance experience preferred.

Strong understanding of GMP

Strong quality awareness

Fluent in German and English, both spoken and written.

IT skills in MS Office, SAP

Good prioritization skills

Good teamwork skills and cooperation with colleagues and superiors

Solution-oriented thinking

Independent work style and ability to independently familiarize oneself with workflows and processes.