Job Purpose
Support the company in maintaining quality standards throughout its operations. This role requires a thorough knowledge of Good Manufacturing Practice, current FDA and 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, implementing and maintaining standards of GLP practice consistent with regulatory expectations and cGMP.
2. Responsible for guiding a team of QC analysts/technicians, including performance management and executing 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 perform to a high standard in achieving company and department goals.
6. Support major Projects, quality plans, and continuous improvement programs within the department and 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, managing them to ensure compliance with acceptable regulations and company policies.
10. Support 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 and communication skills.
6. Problem-solving and good organizational skills.