Team Leader Quality Control
For one of the leading generic pharmaceutical clients in the world, Real Life Sciences is currently recruiting a Team Leader Quality Control.
Team Leader Quality Control Analytical Laboratories Transfer & Implementation
40 hours per week
6 months (temp to perm or extension expected)
Haarlem, the Netherlands
The Quality Control Analytical Laboratory is responsible for all analytical testing to support the production Cytotoxic and Inhalation drug products. The laboratory executes a wide variety of analytical test package to test APIs, excipients, packaging materials and drug products for release and stability purposes. Also the responsible for transfer, validation and verification of analytical methods for testing of new drug products.
Group size: 8-10 FTE
The Team Leader QC- Analytical Laboratory Method Implementation & Transfer is supported by an enthusiastic knowledgeable team consisting out of analysts and project managers, which closely collaborates with different stakeholders, like R&D and MS&T to implement new analytical knowledge about new drug products. The team is also responsible for providing analytical support of process improvements. The Team Leader is responsible to plan the various activities in close collaboration with stakeholders, while remaining aligned with the strategy, commitments and goals of the QC organization.
Manage Method Transfer & Implementation
o Manage the team in establishing and maintaining quality at the lab in accordance with Site SOP's, regulatory guidelines and cGXP compliance requirements.
o Maintain a culture of enhancing quality throughout the entire Laboratory. Performance of in-depth root cause analyses
o Act as SME during regulatory and internal audits.
o Responsible for implementation & transfer of methods which meet the business needs and current regulations.
o Responsible for cross-departmental communication to meet project demands
o Responsible for projects within the entire QC AL department
Manage Team and Resources
o Manage own team through talent identification, active performance management, succession planning, employee development, mentoring and modelling behaviour according to company's values.
o Run an efficient and effective QC Transfer& Implementation team through managing the team budget and resources.
Manage of Culture of Safety
o Maintain a culture of enhancing safety throughout the entire Laboratory.
o Review and provide options to meet business needs without compromising health & safety.
o Bachelor or Master degree in analytical chemistry/pharmacy or equivalent experience
o Able to act as an excellent liaison between Research & Quality
o Good Knowledge with the use of ICH guidelines and Pharmacopoeia methods
o Excellent organizational skills and a strong analytical oriented mindset.
o Experience with working in a pharmaceutical environment
o Solid experience with equivalence, method validation or method verification studies
o Management Experience is preferred (2-3 yrs)
o Good knowledge of Pharmaceutical quality systems and production processes
o Good scientific analytical attitude
o Excellent written and verbal communication skills
o Pro-active team player
o Results oriented
Are you interested in this interesting role? Please reach out to Maarten Rill through m.rill(A)realstaffing.com or call with our office 0031 20 5221588.