GMP Compliance 93093

If you are interested in this opportunity, do not hesitate to contact me at lisa.morfitis@professionals.randstad.be.

Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:

• Minimum 7 years in Pharmaceutical Industry (preferably in an FDA approved context) including minimum 5 years in Regulatory
• GMP knowledge
• Technical understanding of product manufacturing processes and/or testing
• good knowledge in English
• Sense of urgency, flexibility and accountability Enterprise thinking (cross functional team spirit, sharing of good practices within the network)
• Strong quality and results oriented mindset
• creative approach to problem solving and the ability to challenge the status quo
• Ability to work across boundaries
• Customer oriented: ability to active listening to internal customers and pro-actively proposing solutions based on their needs
• Effective communication and coaching skills
• Effective leading and influencing skills – ability to influence at all levels of management and to energize a team towards to pursue common goals
• Excellent team builder / team player
• Flexible thinking and ability to support/drive changes
• Assertive
• Lean culture spirit

Preferred Qualifications:

If you have the following characteristics it would be a plus:

• Demonstrated ability to quickly understand end to end process
• Demonstrated ability to take full accountability of small or medium project
• Good analytical and problem-solving skills

Consultancy

We offer an attractive salary with extra-legal advantages:

• Group insurance
• Hospitalisation insurance
• Meal vouchers of 7 euros gross per working day
• Reimbursement km or company car
• Monthly allowance (80 euros net per month)
• A 13th month
• Training
• Etc.

A rate is freelance is also possible.

Our client is a global vaccine research, development and production company, that employs over 11,200 people worldwide, of which 7,500 in its three Belgian sites: Rixensart, Wavre and Gembloux.

Your responsibilities:

• You provide Chemistry/Manufacturing/Controls (CMC) and regulatory expertise within Manufacturing Performance Units or Quality Control Department, to ensure continuous alignment of Operations with the approved data by Health Authorities.
• You support Manufacturing Performance Units or Quality Control Department for CMC processes.
• Responsible of quality oversight of source documents and ensure providing the operational documents to support GRA in authoring post approval changes’ variations.
• Approve, on behalf of Operations, submitted documents to Health Authorities in the frame of Regulatory Submission Process.
• Lead Questions & Answers and Commitments process within Manufacturing Performance Units or Quality Control Department.
• Support QA and MPU head in the prioritization of the CMC subjects in their area.
• You oversee Change Control.
• Being responsible for decision making of Regulatory impact of changes (initial assessment of the potential regulatory impact of changes).
• To support Global Regulatory Affairs in defining regulatory strategy on behalf of operations.
• To support Operations in defining implementation and release strategy with regards to Regulatory matters.
• You support MPU/QC head and QA head by being the Single Point of Contact (SPOC) for any decision related to regulatory compliance.
• You are responsible for coaching and developing regulatory awareness of Manufacturing Performance Units or Quality Control Department.
• You are responsible for coaching and developing awareness of MPU/SPU shop floor practices to GRA team.
• You provide technical support to Global Regulatory Affairs (GRA) in communication to and from Health Authorities in the frame of post approval changes management.
• You provide CMC and regulatory conformance expertise to support release of products in compliance with marketing authorization through deviation assessment, visibility to registered details, post approval changes guidance.
• You are empowered to take decision in grey area for regulatory topics.