Achieva Group Ltd

QA Manager

Location
Switzerland
Salary
CHF65 - CHF72 per hour
Posted
24 Mar 2021
Closes
23 Apr 2021
Ref
BH-25558
Contact
Sophie Fosh
Discipline
Quality, GMP, QA / QC
Hours
Full Time
Contract Type
Contract
Experience Level
Management

Our global pharmaceutical client has a vacancy for a QA Manager (GDP/GMP)
 
Our client is looking for candidates based in Switzerland/ EU.
 
This is an initial 12-month full time contract.
 
Job Responsibilities
• 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
 
Candidate’s 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
• 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
• Provide coaching and advice to Junior QA Managers and QA Managers when
required