Hovione is an independent family-owned international group of companies dedicated to helping Pharmaceutical Customers bring new and off-patent drugs to market.
Job Description
We are looking for a skilled Quality Control (QC) professional to join our team at Hovione. As a key member of our QC team, you will be responsible for ensuring the quality of our products and services, adhering to regulatory requirements and industry standards.
Key Responsibilities:
* Define and implement quality control techniques to verify the quality of raw materials, intermediate and end products, as well as any other analytical services relevant to our client base and according to regulatory requirements.
* Manage and control all Quality Control activities in accordance with identified quality assurance standards, company procedures, client specifications, contract requirements, and regulatory guidelines.
* Follow daily priorities to accurately and promptly perform the allocated sample analysis, meeting the requirements of the laboratory plan and area KPIs.
* Adhere to the laboratory testing schedule to achieve an efficient Quality Control (QC) system.
* Take responsibility for all data individually generated and ensure compliance with all applicable GMP requirements and HSE regulations, adhering to all relevant Operating Procedures and industry standards in conducting all analytical activities.
* Maintain all checklists, laboratory records, and notebooks to an acceptable GMP standard and in accordance with Hovione internal procedures.
* Maintain good hygiene and housekeeping within the laboratory.
* Perform routine calibration and both corrective and preventative maintenance of designated laboratory instruments, requesting any instrument parts and consumables required by the area.
* Comply with the high standards in the QC Laboratories.
* Report any discrepancies, deviations, or non-conformance in testing or work practice to QC management in accordance with Hovione internal procedures.
* Issue events and support the investigation of OOS/OOT/atypical results, deviations, and QC incidents generated in the QC Laboratories.
* Ensure appropriate communication with other internal departments regarding QC work by using the appropriate Hovione processes and their IT platforms.
* Undertake any additional tasks to support laboratory activities as required.
* Seek out additional information when the available information is insufficient.
* Follow all annual performance review requirements, including completion of the self-assessment.
* Carry out assigned tasks and duties safely, in accordance with instructions, and comply with environmental, health & safety rules/procedures, regulations, and codes of practice.
* Ensure facility activities are carried out in compliance with all GMP, legal, and HSE regulations and applicable standards in the country of operation, complying with and enforcing all Hovione processes and good practice.
Requirements:
* Qualification in a relevant chemistry, analytical chemistry, chemical engineering, pharmaceutical-related or other science-related field (strong preference).
* Proven practical pharmaceutical or related industry experience in a GMP regulated QC laboratory environment (preferable).
* Experience of GMP practices and HSE standards (preferable).
* Technical understanding of GMP practices, analytical theory, and techniques.
* Clear and open communication skills (written and verbal).
* Competent (written and verbal) English (preferable for sites where English is not the first language).
* Ability and availability to work in shift patterns, as required by business needs.
* Computer literate with knowledge of the MS Office package.