If it's worth doing, it's worth documenting
Over de functie
Yacht Life Sciences has a vacancy for a position as a Quality Assurance (QA) Manager Pharmaceutical Documentation at our client, a multinational pharmaceutical company.
In this role, you will manage employees of the Pharmaceutical Documentation Department. This includes that you will maintain a team that has the technical expertise, personal skills and interpersonal skills needed to perform their duties in line with company and site expectations. Also, you will instruct employees and delegate duties in consultation with the persons involved. As the QA Manager you ensure an effective internal communication structure with relevant departments, supervise the performance of the work as well as the lead time, and measure and monitor departmental quality key performance indicators.
As a QA Manager you will manage department processes, including and not limited to the coordination of SOP’s, DCRF’s, Analytical Procedures and BMR’s. You will manage your team through talent identification, active performance management, succession planning, employee development, mentoring and modeling behavior. Importantly, you will create team spirit within the department, you review the performance of employees and provide training opportunities. Furthermore, you will maintain a team that understands and maintains the rigorous standards required while retaining the flexibility to adapt to continuous evolution and change.
As a QA Manager you will manage the activities of the Pharmaceutical Documentation Department. You will ensure that SOPs are developed according to cGXP guidelines and global requirements, you will manage the documents in a robust electronic document management system and ensure proper archiving for non EDMS documents. Also, you will support QC to assure that analysis methods are in accordance with USP/ Ph. Eur/ JP and files. Next, you will prepare and implement department policies and objectives in line with company and site policies, ensure the implementation of and compliance with national and international quality standards (cGXP) as well as global standards, and ensure that all current SOPs are accurate, current with regulatory guidance and aligned with cGXPs. Furthermore, you make proposals for the allocation of workloads and resources to meet compliance and business requirements, as well as with regard to organization structure, staffing, and training.
As a QA Manager, you will coordinate with Quality Leadership. You are an active member of the Quality Systems Management Team and help to define policy development. You share best practices, challenges and lessons learned within the site across the site in order to improve the performance of quality. In addition, you will translate objectives into local objectives, monitor and adjust day-to-day performance and operations, cooperate in the preparation of long-term local strategy, and interact in local & global platforms.
As a QA Manager you will be the Face of the Site. You develop a productive and proactive attitude during regulatory inspections and global audits, and represent the site from a quality perspective to customers, professional and trade organizations, the public and other external sources.
As a Quality Assurance Manager, you must have:
- a BSc degree or higher with several years of experience in a manager position in the pharmaceutical industry
- experience with documentation systems and processes, pharmaceutical processes, techniques, and cGXP
- proven management and team-lead capacities
- familiarity with Laboratory Procedures
- knowledge of relevant regulatory guidances
- knowledge of Quality Management Systems
- knowledge of Product types and/or profile codes
- the ability to promote continuous process improvement/ efficiency
- excellent communication (both English and Dutch), risk management, decision making, and problem solving skills
To be discussed with our client where the candidate will be appointed directly.
Our client is an allround pharmaceutical company, active in all segments of the pharmaceutical market.
Voor meer informatie neem je contact op met Edwin Parlevliet via telefoonnummer +31 0612387998
Werken voor Yacht
Yacht is dé organisatie van en voor professionals. Wij verbinden professionals en organisaties die het verschil willen maken. Ons doel is optimaal resultaat: jou als professional uitdagend werk bieden waarmee jij de organisaties van onze opdrachtgevers blijvend verbetert. Behoor jij tot de beste professionals in jouw vak? Wil je samen met vakgenoten het verschil maken bij toonaangevende organisaties? Dan willen we jou graag leren kennen.
Uiteraard staat deze vacature open voor zowel mannen als vrouwen.