Quality Assurance Manager | Innovative Pharma | 1-Year Contract

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View: 122

Update day: 03-04-2024

Location: Basel Basel-Stadt BS

Category: Quality Assurance / Quality Control

Industry: Staffing Recruiting

Position: Mid-Senior level

Job type: Contract

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Job content

I am currently seeking a highly motivated and experienced Quality Assurance Manager to join my client’s team on an initial 1-year contract.

My Client is a dynamic and innovative pharmaceutical company dedicated to discovering, developing, and bringing to market innovative medicines to meet the unmet needs of patients.

In this position you will play a pivotal role in ensuring the quality and safety of cutting-edge pharmaceutical products throughout the entire lifecycle, from development to commercialization.

Responsibilities

  • Provide GMP/GDP quality assurance expertise during the development and commercialization of our cutting-edge pharmaceutical products.
  • Ensure the initiation and completion of all required quality activities according to the development stage, seeking guidance from management when necessary.
  • Guarantee that our medicinal products are designed, developed, manufactured, and controlled in accordance with the highest quality standards.
  • Offer guidance for the resolution of quality-related issues such as complaints, testing problems, deviations, and investigations, proposing Corrective and Preventive Actions (CAPA) as needed.
  • Establish a quality risk management approach based on six sigma concepts and ensure that quality is managed throughout the product life cycle.
  • Manage activities to support the release of active ingredients, commercial products, and investigational medicinal products, including documentation approval and batch record review.
  • Proactively identify and notify the team of potential quality, regulatory, and lead time issues.
  • Represent and advocate for quality activities in CMC team meetings.
  • Assist in conducting GMP/GDP onsite audits at Contract Manufacturing Organizations (CMOs).
  • Collaborate in the preparation of GMP/GDP Agreements with CMOs.
  • Write, review, and approve internal SOPs and other GMP/GDP-related documentation.
  • Contribute to the review and optimization of our pharmaceutical quality system, proposing improvements and modifications as needed.
  • Participate in the release of Drug Substance (DS) and Drug Product (DP) Bulk as defined in relevant SOPs.

Requirements

  • A Master’s degree in Pharmacy, Chemistry, or a related technical/scientific field,
  • 3-6 years of experience in quality assurance of drug substance and/or drug product.
  • Solid knowledge of drug substance and/or drug product development, manufacturing processes, quality control, packaging, and distribution.
  • Familiarity with (c)GMP/GDP’s (Current Good Manufacturing Practices and Good Distribution Practices).
  • Strong project management skills and the ability to prioritize tasks effectively.
  • Proactive approach to initiating and leading quality activities.
  • Fluency in English and at least basic knowledge of an additional European language, with German or French being advantageous.

If you are looking for a new and refreshing role or have any questions about the position, then give me a call, drop me a message, or apply directly below and get ahead of the crowd! I look forward to hearing from you.

For a confidential discussion about this role, or to apply, then send your CV to c.buckley@nonstop-recruitment.com or call me, Corey Buckley, Recruitment Consultant - Life Sciences - Switzerland, at +41 435 080 817 (intern 3117). Please feel free to visit my LinkedIn profile to see my references/recommendations.

NonStop is one of the largest and fastest-growing specialised life sciences recruitment companies in Europe. We are proud members of the APSCo life sciences group who ensure we meet the highest quality standards within the recruitment industry. Our offices are located in the UK, Luxembourg, Switzerland, Romania, the US and the Czech Republic and we hold labour leasing licences across
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Deadline: 18-05-2024

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