We are seeking a Quality Control Team Lead to join our Quality Control Department. The role involves maintaining quality standards across the company and ensuring compliance with Good Manufacturing Practice (GMP) and current FDA & EMEA regulations for solid oral dosage pharmaceuticals. A strong understanding of manufacturing and packaging processes within the pharmaceutical industry is required.
KEY RESPONSIBILITIES
1. Ensure the QC laboratory adheres to Good Laboratory Practice (GLP) and Good Manufacturing Practice (GMP) standards.
2. Maintain compliance with regulatory expectations and current GMP (cGMP) guidelines.
3. Investigate and address non-conformance issues, instrument malfunctions, and other anomalies.
4. Oversee validation, operation, maintenance, calibration, and troubleshooting of laboratory instruments.
5. Approve and maintain relevant QC documentation.
6. Ensure compliance with LIMS/Empower systems and other regulatory systems.
7. Provide guidance and performance management for a team of QC analysts and technicians.
8. Support and mentor team members to ensure high performance and goal achievement.
9. Foster a positive and productive team culture by inspiring enthusiasm and engagement.
10. Handle training, recruitment, disciplinary actions, and performance appraisals.
11. Support major projects, quality plans, and continuous improvement initiatives.
12. Ensure that Production, QA, Planning, and Shipping departments receive a high-quality service.
13. Identify and implement new technologies in the QC area.
14. Prepare for and support external audits (HPRA, FDA, corporate, or client).
15. Implement and maintain safety standards to ensure a clean, tidy, and safe working laboratory.
16. Promote a strong culture of safety awareness and ensure proper reporting of incidents.
17. Participate in cross-functional training initiatives.
18. Ensure timely completion of all SOP readings, training, and assessments.
19. Perform other duties as assigned by the Manager, Compliance, or other senior staff.
20. Act as the designee for the Manager, QC Laboratory in their absence.
PROFILE
1. BSc. in Science or a related discipline (minimum requirement).
2. 5+ years of experience in an analytical lab, preferably with supervisory responsibilities.
3. Strong technical expertise in GC (Gas Chromatography) / HPLC (High-Performance Liquid Chromatography) Analysis.
4. Experience in continuous improvement initiatives within a QC environment.
5. Proven experience in managing, motivating, and leading a team of analysts.
PRACTICALITIES
1. Hybrid opportunity
If this description resonates with you, and you would like to find out more, don't hesitate to shoot me a message on v.niesov@panda-int.com!
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Quality Assurance
Industries
Pharmaceutical Manufacturing
#J-18808-Ljbffr