QA Manager

Flexsis; Allschwil; On-site; CHF 110,000 - 140,000; Full time

Job summary

Flexsis is seeking a highly capable quality assurance professional to support GMP/GDP-compliant development and commercialization of medicinal products in Switzerland. You will ensure QA activities are initiated and completed according to development stage and applicable quality standards.

Responsibilities include guiding on complaints, deviations, OOS investigations, CAPA, and risk management, plus release support for DS/DP batches and collaboration with CMOs and CMC teams.

Qualifications

• University degree in Pharmacy, Chemistry or related field: master level minimum.
• 3–6 years of experience in pharmaceutical product development/ quality control / analytical development / chemical production or similar roles.
• 3–6 years of experience in quality assurance of drug substance and/or drug product.
• Knowledge of drug substance and/or Drug Product development, manufacturing, quality control, packaging and distribution.
• Good knowledge of cGMP/GDPs.
• Ability to interpret and implement Quality standards.
• Ability to manage complex projects and prioritize workload.
• Ability to pro-actively initiate and lead quality 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 basic knowledge of an additional language (German or French advantageous)

Responsibilities

• Provide GMP/GDP quality assurance expertise during development and commercialization of clients products.
• Ensure QA activities are initiated and completed according to the development stage.
• Ensure products are designed, developed, manufactured and controlled to adequate quality standards.
• Guide on complaints, testing issues, deviations and OOS investigations and CAPAs as needed.
• Establish a quality risk management approach in projects, incorporating Six Sigma concepts.
• Support release of active ingredients, DS and DP batches and assessment of change controls.
• Notify CMC team and management of potential quality, regulatory and lead time issues.
• Participate in, represent and defend quality activities in CMC team meetings.
• Prepare GMP/GDP agreements with CMOs and the CMC team.
• Write, review, and approve internal SOPs and other GMP/GDP documentation.
• Support review and optimization of the pharmaceutical quality system via KPI reviews.

Skills

GMP/GDP knowledge

Quality Assurance

CAPA & investigations

Six Sigma knowledge

Project management

Stakeholder management

English fluent

German/French beneficial

Education

Master degree in Pharmacy, Chemistry or related field

Job description

The purpose of our client is to discover, develop, and commercialize innovative medicines to help more patients.

• Provide GMP/GDP quality assurance expertise during development and commercialization of clients products
• Ensure all required quality activities are initiated and completed according to the development stage
• Ensure that medicinal products are designed, developed, manufactured and controlled according to adequate quality standards
• 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
• 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
• 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
• Preparation of GMP/GDP Agreements in collaboration with CMOs and the CMC team
• 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
• Release of DS and DP Bulk as defined in the relevant release SOPs

• 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
• Ability to manage complex projects and prioritize workload according to the project importance
• Ability to pro-actively initiate and lead quality 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 language, German or French advantageous