Associate Specialist QA Operations

vor 2 Wochen

Couvet, Schweiz WuXi AppTec Vollzeit

QA Operations Team is dedicated to actively supporting the Couvet site and other departments to ensure compliance with cGMP processes and products.

This role involves quality assurance (QA) primarily focused on reviewing bulk or packaged commercial drug products, raw material batches if necessary, and maintaining relationships with QA departments at contract facilities. The responsibilities include supporting on-site QA activities such as deviations, CAPA, OOS, change control, batch release, archiving, and handling complaints. The position may require working in 2*8 shifts at the Couvet site. As a member of the Quality Operations team, the position is expected to be a reliable source of information and guidance on quality and cGMP compliance requirements. Additionally, the role involves identifying and addressing packaging, warehouse, bulk/QC, and cGMP compliance issues. Other duties include managing quality metrics, conducting risk assessments, and assisting with health authority inspections and corporate audits.

This role works closely with QA Operations management to identify and resolve process quality and cGMP compliance issues, ensure efficient release of finished/semi-finished products, bulk materials, or raw materials for production, and contribute to process enhancements within their scope of work.

This is a Long Term Temporary Position

The individual in this position is accountable for the following tasks. This list is not exhaustive, and additional responsibilities may be assigned based on business needs.

  • Supports the development of Master Batch Records for bulk or packaged commercial drug products.
  • Reviews executed batch records and associated QA samples (API, raw materials, bulk, semi-finished, and finished products) on the floor when applicable.
  • Ensures compilation and archiving of documentation for GMP compliance.
  • Manages deviations, complaints, and CAPA activities related to the Couvet site and ensures proper execution and follow-up of escalation procedures.
  • Collaborates with partners on GMP activities.
  • Drafts, revises, and provides recommendations for SOPs and quality documents for the Quality department and supported departments at the Couvet manufacturing site.
  • Handles qualification and validation documentation for QA review of relevant documents/reports (DQ, IQ, OQ, PQ, Cleaning Validation, Process Validation) and supports their execution.
  • Supports during Authorities inspections and internal audits when required.
  • Represents QA in department and cross-functional project teams as needed.
  • Participates in recommendations for continuous improvements in Quality systems.
  • Contributes to regular reporting of quality process metrics.
  • Ensures compliance with product security regulations and established work methods within the area of responsibility.

Experience / Education

  • BS in a scientific or related discipline.
  • Minimum of 1-2 years of experience in Quality Control and/or Quality Assurance in a pharmaceutical company or related industry.

Knowledge / Skills / Abilities:

  • Thorough understanding of cGMPs and regulatory requirements from Swiss, EU, and FDA.
  • Comprehensive knowledge of Solid Oral Dosage in packaging, warehousing, bulk, and QC processes.
  • Outstanding interpersonal, collaborative, and organizational skills.
  • Ability to work independently and in a team effectively.
  • Strong written and verbal communication skills in both French and English.
  • Excellent investigative and problem-solving skills, with a focus on quality and decision facilitation when needed.
  • Attention to detail and ability to multitask in deadline-driven environments.
  • Collaborative, organized, responsible, reliable, team-oriented, initiative-driven, and service-oriented.
  • Proficiency in common office software.

An Equal Opportunity Employer. All qualified applicants will be considered for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status, and will not face discrimination based on disability.

This job description acknowledges that the listed responsibilities are not exhaustive. Individuals in this position may be required to perform other job-related duties as directed by Management.

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