gmp compliance 93093

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

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.

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.