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GMP Quality Management System Specialist Belgium,
Keyrus Biopharma (company)
Posted on : 02 June 2017
As GMP Quality Management System Specialist, you will join a team on client s site to work on the implementation and the maintenance of an effective Quality Management System. You will be in charge of the following
- Local technical operations related to the manufacturing of pharmaceutical products complies with applicable national and/or international regulations and guidelines (GMP) & relevant to the company's quality policies.
- Marketed pharmaceutical products are manufactured and supplied in accordance with the company's product Quality Standards.
- To pro-actively help operations identify, develop and implement quality and operational excellence improvements in response to business requirements, technical changes and regulatory requirements.
- Under the responsibility of the Head of QA Injectable Manufacturing and in close relationship with Injectable Manufacturing department ensure the following relevant QA tasks are timely performed:
- Participation to continuous improvement and product life cycle management
- Technology Transfer
- Process validation
- Equipment qualification
- Cleaning validation
- Stability studies
- Filing submission preparation and follow up of RA commitments
- Review/approval of Change control, Failure investigation, Deviations, CAPA plans
- Authoring and follow up of Product Quality Review
- Review and authorization of relevant SOP
- Provide support in the preparation and execution of internal / external audits.
- Assist Manager to achieve team objectives.
- Act as back up for other team QA Officers and Assistants according to Manager instructions
Education and Professional Background :
- Minimum of 5 years in a regulated pharmaceutical environment, including a minimum of 2 years experience in Quality Assurance (QMS & audit included) and/or Sterile Manufacturing. Experience with GMP is needed.
- Has demonstrated a fact based decision making process, accountability and delivering attitude
- Knowledge of worldwide regulations pertaining to GMP and the company's policies and procedures.
- Excellent oral and written communication skills.
- Fluent in English, French is an asset
- Excellent interpersonal relationship skills.
- Well developed sense of discretion and ethics.
- Excellent team player attitude.
- Stress resistant
Independently identifying, communicate and initiate problem solving process
What we offer
- You will receive a competitive based salary depending on your education and experience in an attractive package of extralegal benefits (company car, petrol card, meal vouchers, group insurance, hospitalization &).
- Each employee will be welcomed with a varied integration program.
- We invest considerable time and resources in training our staff (technical and non-technical courses).
- You will join a dynamic and international environment with enthusiastic and professional colleagues.
Who We are
- Our company is an international Consulting, Contract Research Organisation and Functional Services provider with a reputation for transparency and integrity, highly focused on being able to deliver with excellence.
- Our human approach to service provision is what differentiates us from our competitors.
- Combined with our high caliber staff, this approach has allowed us to become a key player in clinical research.
- We re proud of our commitment to delivering services of the highest quality, not only skillfully, efficiently and reliably, but also with sincerity and genuine care for our clients projects, priorities and reputation. Thus we maintain and advance our vision and our standards, all the while ensuring that we serve your interests better
- From early- to late-stage drug development, our range of services includes: Project Management, Clinical Operations, Pharmacovigilance, Quality Assurance (GxP), Regulatory Affairs Strategy & Support, Data Management, Medical Review & Coding, Bio statistics, Medical Writing & Medical Information, Real World evidence services.
Walloon Brabant Belgium
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