QA Manager - GMP/GDP

CHF95 - CHF100 per hour
  1. Interim/Contract
Basel
  1. Quality Assurance
Posted:11/05/2020
BBBH13974

Hobson Prior are looking for a QA Manager - GMP/GDP to provide GMP/GDP quality assurance expertise during development and commercialization of products. You will join a growing biopharmaceutical company in Switzerland who focus on discovering, developing and bringing more, pioneering medicines to patients.


Job Responsibilities:

  • Accountable to ensure all required quality activities are initiated and completed according to the development stage with advice from management.
  • For assigned projects, provide guidance on the resolution of complaints, testing issues, deviations, discrepancies and Out of Specifications, investigations and propose Corrective and Preventive Actions as needed, with advice from management.
  • Ensure that medicinal products are designed, developed, manufactured and controlled according to adequate quality standards with advice from management.
  • Establish a quality risk management approach in projects based on six sigma concepts and training to ensure that quality is understood and managed by all stakeholders throughout the product life cycle, with advice from management.
  • Manage all required activities to support release of active ingredients, commercial products and/or investigational medicinal products including approval of master process documentation, batch record review and assessment of change controls.
  • Notify CMC team and management of potential quality, regulatory and lead time issues.
  • Partake, represent and defend quality activities in CMC team meetings.
  • Assist GMP/GDP onsite audits at Contract Manufacturing Organizations on demand.
  • Preparation of GMP/GDP Agreements in collaboration with CMOs and the CMC team, with advice from management.
  • Write, review, and/or approve internal SOP's and other GMP/GDP related documentation.
  • Support review and optimization of the company's pharmaceutical quality system by preparing review of relevant CMO's Key Performance Indicators.
  • Pro-actively participate to the optimization of the quality system by proposing new procedures, tools or modification of existing ones.

Key Skills:

  • Capability to interpret and implement Quality standards with advice from management.
  • Ability to manage complex projects and prioritize workload according to the project importance.
  • Ability to pro-actively initiate and lead quality activities with coaching from management.
  • Self-confident, assertiveness and autonomy to deal with complex stakeholders/situations with some advice from management.
  • Ability to communicate clearly and professionally both verbally and in writing.

Requirements:

  • University degree in Pharmacy, Chemistry or alternative technical/science university degree: master level minimum.
  • 3-6 years of experience in different positions like pharmaceutical product development/ quality control/ analytical development/ chemical production or similar operational positions in the pharmaceutical industry.
  • 3-6 years of experience in quality assurance of drug substance and/or drug product.
  • Knowledge and understanding of drug substance and/or Drug Product development, manufacturing process, quality control, packaging and distribution.
  • Good knowledge of (c)GMP/GDP's.
  • Fluent in English and at least basic knowledge of an additional European language, German or French advantageous.

Apply now:

If you are interested in learning more or applying to this exciting opportunity, please complete the form below and attach a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist, please request a call back at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.

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