QA – Batch Record Review Specialist Permanent

QA – Batch Record Review Specialist

Job Overview:

The primary purpose of this role is to facilitate the smooth certification process of Qualified Person by providing essential documentation support. The incumbent will play a crucial role in ensuring that all necessary documents are in place for QP certification, batch record reviews, and timely batch releases.

Key Responsibilities:

• Manage client sharepoints and facilitate the transfer of files into study folders.
• Batch Record Review: Scrutinize client-provided batch records to ensure completeness and accurate batch genealogy.
• Review manufacturing and testing batch records as part of the quality assurance process.
• Documentation Preparation: Prepare checklists and certificates required for QP batch release.
• Assist QPs in addressing various quality assurance-related tasks, CAPA and deviation management.
• Coordinate release activities, with a focus on meeting delivery timelines.
• Analyze Key Performance Indicators related to lead times and right-first-time outcomes.
• Request any missing documents from Project Management.
• Regularly liaise with the team to determine document requirements and provide requested documents.
• Provide support in other quality-related areas.
• Contribute to QP release planning activities.

Qualifications:

• Candidates should have prior experience in a similar role within a company holding a Manufacturer’s Import Authorization. Alternatively, a background in pharmacy or life sciences is preferred.
• Demonstrated experience in the quality department of a pharmaceutical company with knowledge of current cGMP.
• Familiarity with manufacturing procedures for various dosage forms, including solid and sterile formulations.
• Understanding of risk analysis and related methodologies, as well as knowledge of regulatory guidelines such as ICH, GAMPs, Annex 11, and Eurdalex guidelines.
• Proficiency in business-level German and English for effective communication.
• Strong interpersonal and written communication skills
• Dedication to upholding quality assurance principles.
• Self-motivated and highly organized, with the ability to work independently and as part of a team.