Quality Control Team Leader

4 weeks ago

Bray, Ireland Asset Recruitment Full time

ref. 01261

Quality Control Team Leader

Job Purpose

Support in maintaining quality standards throughout the company. This role requires a thorough knowledge of Good Manufacturing Practice, current FDA & EMEA regulations for solid oral dosage pharmaceuticals for human use and a good working knowledge of manufacturing processes and packaging processes used in the pharmaceutical industry.

Key Responsibilities

1. Ensure that the QC lab is in compliance with Good Laboratory Practice/Good Manufacturing Practice. Implement and maintain standards of GLP practice consistent with regulatory expectation and cGMP.
2. Responsible for all aspects of guidance of a team of QC analysts/technicians, including performance management and the execution of business processes to a high standard as monitored.
3. Validation, operation, maintenance, calibration and troubleshooting of laboratory instruments.
4. Ensure that Production, QA, Planning, Shipping and support departments receive a quality service through meeting scheduled target release dates and compliance standards.
5. Support your team and help them to perform to a high standard, in the achievement of the company and department goals.
6. Support major Projects, quality plans and continuous improvement programmes within the department and in others.
7. Prepare for and support external audits (HPRA, FDA, corporate, or client).
8. Highlight and implement new technologies in the QC area.
9. Maintain the validated status of the LIMS/Empower systems and other relevant systems and manage them to assure compliance with acceptable regulations and company policies.
10. Support of Annual Product Reviews.
11. Act as designee for Manager; QC Laboratory in their absence.

Requirements

1. BSc. (minimum) in science or a related discipline.
2. 5 years+’ experience in an analytical lab preferably with supervisory responsibilities.
3. Technical experience of GC / HPLC Analysis required.
4. Experience with continuous improvement plans within the QC environment.
5. Experience managing, motivating and leading a team of analysts.

Skills/Competencies

1. Promote teamwork by fostering a supportive and inclusive team atmosphere and focusing people on priorities to guide them in achieving their goals.
2. Address performance issues and establish specific plans to help team members reach their goals.
3. Provide team members with constructive feedback, coaching and support to help them recognize their strengths and development needs.
4. Good investigational and technical writing skills.
5. Strong interpersonal & communication skills.
6. Problem-solving and good organizational skills.

*Maternity Leave Cover*

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