- Fulltime position in a pharmaceutical company

- Lead a team of 4 people

- Working in a dynamic production environment

Tasks

• Ensuring compliance with the Manufacturing License as required by the relevant legislation

• Implementation and continuous improvement of the Quality Management System in order to ensure

current regulatory requirements

• Preparation and implementation of internal policies and SOPs

• Handling of Change Control Requests, Non Conformities, Deviations, CAPAs, Risk Assessments,

Complaints and ensuring their adequate and timely closure

• Responsible Person for GDP (Good Distribution Practices)

• Participation in and approval where appropriate: Annual Product Quality Review, Complaint

Investigations, Supplier Investigations, Quality Continuous Improvement Projects, Technology

Transfer

• Reviewing and approving validation protocols, validation reports, inter lab studies,…

• Support audit readiness

• Conducting internal and external audits (Self inspections and supplier audits), regulatory and

costumer audits.

• Draft and negotiation of Quality Agreements

• Review and formal approval/release of technical reports and/or batch records in compliance with the

regulations

• Supervising the Qualification / Validation activities according to the VMP.

• Being the primary contact person for the Notified bodies and regulatory authorities regarding

Medical Devices & Food Supplements.

• Managing 'Out Of Specification' results, complaints, deviations, extended investigations.

• Advising the different departments and R&D actors on aspects related to quality control & quality

assurance.

• Contributing to operational and strategic initiatives

• Lead and coach a team of 4 people

• Report to the executive vice president of the company

Profile

• You have a scientific Master degree (Pharmacy, Chemistry…) or equivalent by experience.

• Experience in the pharmaceutical industry, preferably pharmaceutical GMP production, primary and

secondary packaging. Experience in leading and coaching a team.

• A thorough knowledge of EU healthcare legislation and quality requirements, knowledge of ISO 13485

& GLP is an asset.

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• In depth understanding of GMP and QA systems is essential including interpreting current regulatory

requirements.

• Excellent planning & management skills, accuracy and attention to detail.

• You have problem-solving capacities and you have preferably experience with validation and with

improvement projects.

• You have the technical competency to evaluate investigations, product and quality issues, etc.

• Ability to cope effectively with pressure and setbacks and maintain commitment.

• Excellent English in writing and speaking, Fluency in Dutch, French writing and speaking is an asset.

Offer
Conforma offers you a broad and varied job with real responsibilities in an ambitious and growing
pharmaceutical company. You receive a competitive salary supplemented with fringe benefits (including
insurance and meal vouchers) and you end up in a pleasant working environment with attention for employees.
Interested? Send your resume to annelies.heynssens@conforma.be and mention the title of the position in
the subject or contact Annelies Heynssens by +32 498 17 66 93.