QA Documentation Specialist

Purpose of the Role Responsible for reviewing executed paper-based batch records to ensure manufacturing activities were performed according to GMP procedures, internal SOPs, and regulatory requirements. The role requires strong attention to detail, independence, and a solid understanding of pharmaceutical manufacturing processes.

Key Responsibilities

• Review executed paper-based batch records within agreed timelines.
• Verify compliance with GMP requirements, SOPs, and manufacturing procedures.
• Track, monitor, and report batch review progress and critical release metrics.
• Support on-time batch release activities.
• Identify observations/deviations and raise them with Operations in a timely manner.
• Participate in discussions and meetings related to batch documentation findings.

Required Qualifications

• Bachelor's or Master's degree in:
  • Pharmaceutical Technology
  • Biotechnology
  • Chemistry
  • Pharmacy
  • Or another relevant scientific discipline
• Equivalent industry experience may be considered.

Required Experience

• Minimum 2 years of GMP experience in a pharmaceutical or biotech manufacturing environment.
• Experience with quality procedures and SOP execution.
• Batch Record Review experience is highly preferred.
• Knowledge of pharmaceutical manufacturing documentation and compliance requirements.

Required Skills

• Strong attention to detail.
• Ability to work independently.
• Excellent communication and stakeholder management skills.
• Strong understanding of GMP regulations and documentation practices.

Language Requirements

• Business-fluent German (mandatory)
• English preferred.

Working Model

• 100% On-Site in Visp
• No home office / remote work option.
• Paper-based documentation environment.

Ideal Candidate Profile

A GMP professional with pharmaceutical manufacturing experience who has hands-on exposure to batch record review, is highly detail-oriented, fluent in German, and capable of managing documentation review timelines to support compliant and timely batch release.