QA Compliance Manager

Reference Number: 895605-W
Type of placement: Permanent, Permanent
Location: Switzerland, North West

Introduction:

One of our clients, a pharmaceutical company, is currently looking for a QA Compliance Manager.

Main Responsibilities:

  • Ensure GMP compliance of external (and deputize internal) facilities, utilities, systems and equipment
  • Manage, review and approve change controls, deviations and CAPAs related to the internal pharmaceutical operations facilities
  • Manage, review and approve of qualification & validation documents of GMP equipment (facilities and utilities)
  • Write, review, and/or approve internal quality system SOPs and other GMP/GDP and regulatory related documentation
  • Evaluate, develop, establish, and maintain internal processes and procedures for compliance with GMP / GDP standards and for process improvement (QS document including Quality agreements with third parties)
  • Administer systems to monitor (KPIs), track, and trend regulatory compliance (e.g. deviations, CAPA, investigations, complain, change control etc.)
  • Manage filing process and system for all quality documents
  • Administer system for e-documentation (e.g. CMC-itrack)
  • Establish External QA Audit and internal self-inspection Frequency based on Risk Assessment, as appropriate. Prepare and/or participate to the annual audit Plan.
  • Coordinate and conduct GMP / GDP  audits and self-inspections; write corresponding audit reports
  • Promptly report critical self-inspection findings to the Responsible Person and management
  • Coordinate, plan and manage Regulatory Agency Inspections
  • Support preparation of Regulatory Agency Inspections
  • Notify management of potential quality and regulatory issues
  • Monitor changes in quality regulations and initiate required activities to keep the quality system aligned and compliant
  • Support  optimization of the company’s  pharmaceutical quality system by preparing for the review of relevant Key Performance Indicators
  • Pro-actively participate to the optimization of the quality system by proposing new procedures, tools or modification of existing ones

Qualifications and Experience:

  • Minimum 5 years of experience in different positions like pharmaceutical product development/ quality control/ analytical development/ chemical production or similar operational positions in the pharmaceutical industry
  • Minimum Master level degree in Pharmacy, Chemistry or alternative technical/science university degree
  • Knowledge and understanding of drug substance and/or Drug Product development, manufacturing process, quality control, packaging and distribution
  • Experience in quality assurance of drug substance and/or drug product
  • Excellent knowledge of relevant GMP/GDP and international quality regulations: ICH, ISO, WHO, PIC, FDA, EU GMP Guide (EudraLex Vol. 4), EU GDP
  • Ability to interpret and implement Quality standards
  • Ability to manage complex projects and prioritize workload  according to the project importance
  • Ability to pro-actively initiate and lead quality compliance activities
  • Ability to manage multiple tasks with competing priorities
  • Good interpersonal and influencing skills
  • Self-confident, assertiveness and autonomy to deal with complex stakeholders/situations
  • Ability to communicate clearly and professionally both verbally and in writing
  • Fluent in English and at least basic knowledge of an additional European language, German or French advantageous
  • Willingness to travel 30-50% for audits
  • Relevant working/residency permit or Swiss/EU-Citizenship required

Comments are closed.

You are logged in as Name

Upload