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QA Manager GDP/GMP (m/w/d)
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Basel |
Temporary Employment
Job title: QA Manager GDP/GMP (m/w/d)
Industry: PharmaSkills: Quality Assurance, GMP, GDP
Start of project: 04.10.2023
Duration of the project : 12 months
Location: Basel
Tasks:
- Provide GMP/GDP quality assurance expertise during development and commercialization of products
- Ensure all required quality activities are initiated and completed according to the development stage with advice from management
- Ensure that medicinal products are designed, developed, manufactured and controlled according to adequate quality standards with advice from management
- For assigned projects, provide guidance on the resolution of complaints, testing issues, deviations, discrepancies and Out of Specifications (OOS), investigations and propose Corrective and Preventive Actions (CAPA) as needed, 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
- Participate, represent and defend quality activities in CMC team meetings
- Assist GMP/GDP onsite audits at Contract Manufacturing Organizations (CMOs) 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
- Release of DS and DP Bulk as defined in the relevant release of SOPs
Qualifications:
- 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
- Ability 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
- Ability to manage multiple tasks with competing priorities
- Good interpersonal and influencing skills
- 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
- Fluent in English and at least basic knowledge of an additional European language, German or French advantageous
Referenznummer:
Branche:
Beginn des Projekts:
Dauer:
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Kontakt
Lars Uhl
13652
Pharma
04.10.2023
12 months
Temporary Employment
