QA expert – Belgium
Our expert are active in:
1. Validation or qualification
2. Process engineering
3. Product development
4. Quality control projects
5. Quality assurance projects (analyst, project engineers)
6. Project Management in general.
• You are responsible for quality by monitoring and ensuring that processes and actions are carried out according to the applied cGMP quality standards:
• You follow written documents such as procedures, protocols and reports concerning the quality systems of other departments;
• You provide QA support and supervision for deviations, change control, CAPA and validation activities
• You will manage and coordinate activities related to deviations and CAPAs
• You manage and coordinate the continuous improvement of deviations and CAPAs and ensure the optimisation of all processes in terms of compliance and efficiency
• You participate in the analysis of quality trends
• You ensure that all major issues impacting the quality system are taken into account, managed and addressed in the action plans
• Facilitation of quality governance meetings
• Managing the quality review of the new metrics file and providing technical support to extend the metrics for process owners.
• Facilitation of quality management review (QMR) meetings.
• You evaluate written events (deviations, OOS / OOL);
• You are responsible for the correction and approval of these procedures, protocols and reports;
• You are responsible for the correction and authorisation of these procedures, protocols and reports; You take care of batch records and laboratory records.
• You participate in various projects related to risk analysis, qualification and validation.
• You will be responsible for carrying out risk analyses and certain corrective and preventive measures (CAPAs)
• You follow up changes via Change Control
• You follow up on initial and routine validations and qualifications
• You participate in or supervise quality-related projects.
• Processing and documenting complaints.
• At least 2 years of relevant experience in GMP.
• You are familiar with many quality tools (Risk Analysis, Fishbone, 6M, 5S…)
• You are able to work in French or Dutch and English
– 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.).
Place de l’Université 16 | Louvain-la-Neuve
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