For our client, a company in pharmaceuticals, we are looking for a Group leader Quality Control Analytical Laboratories Transfer & Implementation based in Amsterdam area.
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.
The group 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 group 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.
- ManageMethod Transfer &Implementation
- Manage the team in establishing and maintaining quality at the lab in accordance with Site SOP's, regulatory guidelines and cGXP compliance requirements;
- Maintain a culture of enhancing quality throughout the entire Laboratory. Performance of in-depth root cause analyses;
- Act as SME during regulatory and internal audits;
- Responsible for implementation & transfer of methods which meet the business needs and current regulations;
- Responsible for cross-departmental communication to meet project demands;
- Responsible for projects within the entire QC AL department.
- Manage Team andResourceses
- Manage own team through talent identification, active performance management, succession planning, employee development, mentoring and modeling behavior according to the client values;
- Run an efficient and effective QC Transfer& Implementation team through managing the team budget and resources.
- Manage of Culture ofSafety
- Maintain a culture of enhancing safety throughout the entire Laboratory;
- Review and provide options to meet business needs without compromising health & safety.
- Bachelor or Master degree in analytical chemistry/pharmacy or equivalent experience;
- Able to act as an excellent liaison between Research & Quality;
- Good Knowledge with the use of ICH guidelines and Pharmacopoeia methods;
- Excellent organizational skills and a strong analytical oriented mindset;
- Experience with working in a pharmaceutical environment;
- Solid experience with equivalence, method validation or method verification studies;
- Management Experience is preferred (2-3 yrs);
- Good knowledge of Pharmaceutical quality systems and production processes;
- Good scientific analytical attitude;
- Excellent written and verbal communication skills;
- Pro-active team player;
- Results oriented.
What do we offer
- Contract via Kelly Services of minimum 6 months (32-40 hours per week), but extension for a long period is expected
- Start date: 01-09-2020
- An international environment where you can learn a lot in challenging projects
When interested please react through the application process with your English resume.
About Kelly Services
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Regarding this role, Kelly Services acts as the official temporary employment agency. When you decide to apply to this role your personal information will be processed in accordance with Kelly's Privacy Statement
In keeping with the AWGB (Algemene Wet Gelijke Behandeling) Kelly Services welcomes applications from any and all eligible candidates regardless of ethnicity, gender, disability, religion, sexual orientation or age.