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QC group leader - Method Implementation & Transfer

  • Job reference: 933491
  • Location: Haarlem, North Holland
  • Salary: Negotiable
  • Job type: Contract
  • Sector: Life Sciences, Quality, Compliance, Regulatory Affairs
  • Date posted: 13/01/2021

Orion Group are currently recruiting an experienced group leader QC- Analytical Laboratory Method Implementation & Transfer, on behalf of one of our Multinational Pharmaceutical Clients based in the North of Holland.

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.


Key activities
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.

Your Profile

- 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


Our role in supporting diversity and inclusion
As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.

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