We are seeking a skilled professional to join our Quality Control (QC) team for a 12-month maternity cover position, responsible for ensuring consistent quality standards across the company. This role requires a solid understanding of Good Manufacturing Practice (GMP), as well as current FDA and EMEA regulations related to solid oral dosage pharmaceuticals for human use. A strong background in pharmaceutical manufacturing and packaging processes is also essential.
Key Responsibilities:
* Ensure the QC laboratory operates in compliance with Good Laboratory Practice (GLP) and GMP standards.
* Lead and guide a team of QC analysts/technicians, handling performance management tasks.
* Uphold safety standards, cGMP, and drive continuous improvement initiatives.
* Support Production, QA, Planning, Shipping, and other departments in meeting quality standards and scheduled release dates.
* Manage training, recruitment, discipline, and performance appraisals for QC analysts/technicians.
* Investigate any non-conformances, instrument malfunctions, accidents, or unusual events.
* Oversee the validation, operation, maintenance, calibration, and troubleshooting of laboratory instruments.
* Contribute to major projects, quality plans, and continuous improvement programs within the department and company-wide.
* Assist with preparations and support during external audits (HPRA, FDA, corporate, or client).
* Ensure safety standards are maintained and the laboratory is clean and safe.
* Identify and implement new technologies in the QC area.
* Maintain the validated status of LIMS/Empower systems and other relevant systems to ensure regulatory compliance.
* Assist with the Annual Product Reviews.
* Act as the designated manager in the absence of the QC Laboratory Manager.
Educational Requirements:
* A minimum of a BSc in science or a related field.
* At least 5 years of experience in an analytical laboratory, with supervisory responsibilities.
* Technical expertise in GC/HPLC analysis is required.
* Experience with continuous improvement initiatives within a QC environment.
* Proven ability to manage, motivate, and lead a team of analysts.
Interested?
Send your CV to Daria at d.finikova@panda-int.com or call +31 20 204 4502 for more information.
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Quality Assurance and Science
Industries
Pharmaceutical Manufacturing and Biotechnology Research
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