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QA Manager Drug Product

Switzerland, Switzerland

  • Salary: CHF80-CHF100 per hour depending on experience
  • Job type: Interim/Contract
  • Posted: 24/06/2019
  • Contact name: Christopher Wise
  • Contact number: 01892 612612
  • Ref: 4461

Job description

Basel Area

12 month contract, full time

QA Manager Drug Product

□ Minimum of 5 years’ experience in different positions like pharmaceutical or chemical development, quality control, analytical development, chemical or pharmaceutical production or similar operational positions in the pharmaceutical industry.
□ In addition, minimum of 3 years’ experience in quality assurance of drug product covering also combination products.
□ Excellent knowledge of GMP and GDP requirements, ability to interpret and implement quality standards.

□ Sound knowledge of drug product manufacturing, control, packaging and distribution procedures.

□ Experience in SAP required.

Job Responsibilities

Provide GMP/GDP expertise thus ensuring that medicinal products are developed, manufactured, packed, labelled, distributed and controlled in accordance with regulatory expectations and applicable quality standards
Perform GMP onsite audits at Contract Manufacturing Organizations (CMOs)
Preparation of GMP/GDP Agreements in collaboration with CMOs and the CMC team
Prepare, review, and/or approve internal SOPs and other GMP/GDP related documentation
Execute QA activities to support release of active ingredients, investigational medicinal products including approval of master process documentation, batch record review, resolution of investigations, and assessment of change controls
Establish a quality risk management approach in projects based on ICH Q9 concepts to ensure that quality is understood and managed by all stakeholders throughout the product life cycle
For assigned projects, ensure resolution of complaints, testing issues, discrepancies, Out of Specifications (OOS) and Corrective and Preventive Actions (CAPA)
Notify management of potential quality and regulatory issues
Support the review and optimization of the company’s pharmaceutical quality system by establishing relevant Key Performance Indicators.
 

Candidate’s Requirements

Advanced University degree in Pharmacy (preferred), Chemistry or alternative technical/science university degree
Minimum of 5 years’ experience in different positions like pharmaceutical or chemical development, quality control, analytical development, chemical or pharmaceutical production or similar operational positions in the pharmaceutical industry
In addition, minimum of 3 years’ experience in quality assurance of drug product covering also combination products
Excellent knowledge of GMP and GDP requirements, ability to interpret and implement quality standards
Experience in SAP required
Sound knowledge of drug product manufacturing, control, packaging and distribution procedures
Strong interpersonal and influencing skills
Excellent verbal and written communication skills in English
Ability to manage multiple tasks with competing priorities
Entrepreneurial mind set combined with cost consciousness
Provide GMP/GDP quality assurance expertise during development and later during commercialization of Idorsia’s products
Perform GMP onsite audits at Contract Manufacturing Organizations (CMOs)
Prepare GMP/GDP Agreements in collaboration with CMOs and the CMC team
Write, review, and/or approve internal SOPs and other GMP/GDP related documentation
Ensure that medicinal products are designed, developed, manufactured and controlled according to quality standards
Establish a quality risk management approach in projects based on ICH Q9 concepts 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, investigational medicinal products including approval of master process documentation, batch record review, resolution of investigations, and assessment of change controls
Notify management of potential quality and regulatory issues
For assigned projects, provide guidance on the resolution of complaints, testing issues, discrepancies and Out of Specifications, investigations and Corrective and Preventive Actions as needed
Support review and optimization of the company’s pharmaceutical quality system by establishing and preparing review of relevant Key Performance Indicators.