Update day: 21-08-2023
Category: Quality Assurance / Quality Control
Position: Entry level
Job type: Contract
Q-People provides targeted solutions in Quality and Compliance projects within Life Sciences, from Pharmaceutical and Biotech to API and Medical Device Production. Training, mentoring and coaching of talent within the Life Sciences sector is our strength. We don’t want specialist knowledge or talent to go to waste. WE PUT PEOPLE FIRST!
Our expert are active in:
- Validation or qualification
- Process engineering
- Product development
- Quality control projects
- Quality assurance projects (analyst, project engineers)
- Project Management in general
Act as the validation representative for small, medium and large process validation projects.
– Define, prepare and implement all validation activities related to the project.
– Develop validation plans: define and document the validation methodology and approach.
– Submit them to the validation manager for review.
– Provide validation expertise for project development.
– Participate in project risk assessment.
– Participate in the definition and drafting of URS, FS and DS.
– Prepare and implement FAT, IQ, OQ and PQ protocols.
– Ensure traceability of requirements throughout the project validation file (from URS to PQ).
– Organise and coordinate FAT, IQ, OQ PQ validation activities with the different departments involved (in the field, if necessary) so that all meet the deadlines set with the project manager.
– Analyse, interpret, document and report test results.
– Ensure the follow-up and traceability of validation activities. Update the validation documentation system.
– Ensure feedback on status and issues to the validation manager.
– Work closely with PV stakeholders (MS, QM, production, quality, regulatory, business excellence) to ensure continuous improvement (e.g. process robustness) by monitoring the critical life cycle of the PV from process development, validation, authorisation submission to routine production.
– Ensure that the validation status of the process is maintained at all times, following established local and global PV strategies.
– Ensure compliance with current GMP and other regulatory requirements and support the drafting of corresponding regulatory submissions and (oral) defences during regulatory audits.
– Contribute to international standardisation for topics related to process validation.
– Provide support for all quality related issues, including GMP regulations, compliance with internal SOPs, and all aspects of safe, reliable and consistent system operation.
– Ensure the ability to meet departmental objectives for EHS, quality, compliance, procurement and budget.
- Master’s degree in engineering, chemistry, life sciences, or any other discipline related to the position or equivalent by experience.
- At least 2 years professional experience in validation/quality systems or similar role.
- Experience of qualification and validation activities in a GMP environment.
- Fluent in French or Dutch AND English.
– The opportunity to co-create the Q-People strategy;
– A career plan and an individual coaching;
– Challenges related to your expertise and ambition ;
– Being part of our community of Q-Consultants and benefit from advice and support from peers;
– Funny moments: team buildings, afterworks, events, etc. ;
– Our Q-Academy offers an broad training programme (hard&soft skills) to strengthen your knowledge and develop your skills;
– A permanent contract and an attractive salary package (13th month pay, hybrid car, petrol card, net allowance, meal vouchers, group insurance, hospital insurance, etc.).
Ana Pardo Pons | Talent Partner
Place de l’Université 16 | Louvain-la-Neuve
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