Associate Manager Raw Materials and NPI Lab

Location
Wicklow (County), Leinster (IE)
Salary
DOE
Posted
22 Feb 2021
Closes
24 Mar 2021
Ref
CP/JO-2102-462532
Hours
Full Time
Contract Type
Permanent
Experience Level
Management

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.

Key Responsibilities:

  • 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.

Qualifications/Experience:

  • 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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