Contract: QC group leader - Method Implementation & Transfer / North HollandClick here to shortlist this job 1-CLICK Apply With Employer or Register Now
|Location:||Haarlem, North Holland|
The client are recruiting an experienced group leader QC- Analytical Laboratory Method Implementation & Transfer.
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 and existing drug products. The team is also responsible for providing analytical support to process improvements. The group/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. He/she is a subject matter expert in method development & validation and an expert in problem-solving.
1. Manage Method Transfer & Implementation
o Guide team in method development and validation strategies
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 and problem solving
o Act as a Subject Matter Expert during regulatory and internal audits.
o Is a Subject Matter Expert with respect to method development& validation.
o Responsible for implementation & transfer of methods which meet the business needs and current regulations.
o Responsible for cross-departmental communication with stakeholders like R&D, MS&T and Operations to meet project demands
o Responsible for projects within the entire QC AL department
2. Manage Team and Resources
o Manage own team through talent identification, active performance management, succession planning, employee development, mentoring and modeling behavior according to the company values.
o Run an efficient and effective QC Transfer& Implementation team through managing the team budget and resources.
3. 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.
- 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