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RP Quality Assurance Officer
Responsible for quality & safety assurance by supervising and coordinating management programs and systems to ensure that the products meet the highest quality standards.
- Determines the tactical and operational direction/priorities (in conjunction with line management) for the continuous improvement of the Site/BU QA management program and systems.
- Responsible Person for the company
- Agrees Quality agreements with external partners (contract manufacturers, logistic service providers and distributors)
- Supports in ensuring ongoing inspection readiness in the areas of responsibilities.
- Support the internal and external audits
- Investigates quality incidents, deviations and complaints, identify and follow-up CAPA’s and supplier improvement plans together with contract manufacturers. and ensure all documentation is updated.
- Evaluates and follow-up change controls as per company procedure
- Develops the Quality Communication Strategy for all levels of staff, to include written information, tool box talks and management briefs.
- Supports the maintenance of the Quality Management system as a SME.
- Writes Product Quality reviews.
- Part of Supplier Qualification and regular Supplier Auditing
- Assists with integration of new product introductions
- Assists in retaining all current quality accreditations and work towards the attainment of new quality accreditations.
- Provides support and expertise to line management in incident investigation and reporting (including dangerous occurrences and occupational diseases).
- Monitors the Site “permit-to-work” system to ensure compliance with standards.
- Identifies gaps and areas for improvement in QA processes and handling/leading remedial actions and initiatives
- Ensures effective training programs have been implemented.
- Keeps a going awareness of new and developing regulations related to GDP’s and GMP’s.
- Advises, assists and pro-actively coaches line management with the implementation of new or existing QA-related legislation, rules and Company standards.
- Advises line management on Site of safety, quality and environmental matters and manages this process to ensure all advice is incorporated into day to day processes and operations.
- Actively promotes a safe working environment for all employees, through leadership by example, installing a culture of zero tolerance and discipline against breaches of the policies, and this throughout all ranks in the organization
Skills and personality
SKILLS AND PERSONALITY
- Master (in pharmaceutical sciences, engineering, biochemistry, chemistry,…) or equivalent through professional experience
- At least 5 years of relevant experience in QA in the pharmaceutical industry
- Good knowledge of the relevant European regulations for manufacturing and distribution of pharmaceutical products
- Strong project management skills
- Speaks and writes fluently English. Other languages are an asset.
- Self-starter, capable of working autonomously
- Clear communicator, practical and solution orientated
- Change management skills
- Balancing entrepreneurial spirit with structure – willingness to adapt to shifting or competing priorities
- Drive for performance (fast decision taking, positive, courage, curious, connected)
- Empower people, look for alignment, teamwork, priority setting, trust, open communication
- Seeks feedback to enhance performance
- Efficiency and effectiveness
- Regular international travel is part of the role.
minimum 5 years
Submit your CV
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