Associate Manager Raw Materials and NPI Lab
- Experience Level
Associate Manager Raw Materials & NPI Lab
On behalf of my client, I am recruiting for an Associate Manager Raw Materials & NPI Lab.
The successful candidate will be responsible for general NPI lab management, reviewing documents, qualification and maintenance of lab equipment, method transfers, recruitment & training of lab techs, driving engagement and CI, supporting change controls, annual product quality review process and supporting audits.
- Responsible for schedule adherence and to ensure that it is met for stability and QC release testing.
- The daily operations, efficient workflows and adherence to strict deadlines.
- You will secure accordance with cGMP/ISO 13485 and regulatory requirements for the activities performed by the section.
- Recruitment and training of staff when appropriate, and performance management of the staff.
- Approve documentation, including maintaining SOPs, work instructions, test methods and worksheets.
- Maintain and validate analytical procedures.
- Review and approve analytical results and handle incidents, deviations, OOS results and change controls.
- Responsible for simplification and improvement of processes in the lab, as well as implementing changes.
- Master of Science degree in Pharmacy, Chemistry, Chemical Engineering, Microbiology or equivalent.
- Minimum 2 years’ experience as a supervisor within a pharma environment.
- Strong understanding of pharmaceutical quality processes and manufacturing processes.
- Experience with LEAN is considered as an advantage.
- Result oriented, able to set and communicate goals and expectations, self-driven and ambitious as well as being fuelled by driving improvements.
- In addition, you possess excellent interpersonal, decision making and team-work skills.
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