Analyst
2 semanas atrás
Our people are the main asset for our continued success. Reaching over 1950 team members, from 36 different nationalities, that are located across Asia, Europe and North America (Portugal, US, Macao, Ireland, China, Hong Kong, Japan, India, and Switzerland), including 4 production sites.
Working at Hovione means reaching for innovation and excellence in everything we do: for our clients, our partners and, above all, our patients. That is why we are In it for life.
You will be responsible to:
1. Define and implement quality control techniques in order 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.
2. Manage and control all Quality Control activities in accordance with identified quality assurance standards, company procedures, client specifications, contract requirements, and regulatory guidelines.
3. Organize and define daily priorities within assigned tasks to accurately and promptly perform allocated sample analysis to meet the requirements of the periodic laboratory plan and area KPIs.
4. Adhere to the laboratory testing schedule to achieve an efficient Quality Control (QC) system.
5. 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.
6. Maintain all checklists, laboratory records and notebooks to an acceptable GMP standard and in accordance with Hovione internal procedures.
7. Maintain good hygiene and housekeeping within the laboratory.
8. Perform routine calibration and both corrective and preventative maintenance of designated laboratory instruments, requesting any instrument parts and consumables required by the area.
9. Comply with high standards in the QC Laboratories.
10. Bring any discrepancies, deviations or non-conformance in testing or work practice to the attention of QC management in accordance with Hovione internal procedures.
11. Issue events and support the investigation of OOS/OOT/atypical results, deviations and QC incidents generated in the QC Laboratories.
12. Ensure appropriate communication with other internal departments in relation to QC work by using the appropriate Hovione processes and their IT platforms.
13. Assist with audits as required, following the instruction of QC Management.
14. Undertake any additional tasks to support laboratory activities as required.
15. Seek out additional information when available information is insufficient.
16. Follow all annual performance review requirements, including completion of the self-assessment.
17. Carry out assigned tasks and duties in a safe manner, in accordance with instructions, and comply with environmental, health & safety rules/procedures, regulations and codes of practice.
18. Ensure facility activities comply with all GMP, legal and HSE regulations and applicable standards in the country of operation, enforcing all Hovione processes and good practice.
We are looking to recruit a Candidate:
1. Qualification in a relevant chemistry, analytical chemistry, chemical engineering, pharmaceutical-related or other science-related field (mandatory).
2. Proven practical pharmaceutical or related industry experience in a GMP regulated QC laboratory environment (mandatory).
3. Experience of GMP practices and HSE standards (preferable).
4. Technical understanding of GMP practices, analytical theory and techniques.
5. Clear and open communication skills (written and verbal).
6. Competent (written and verbal) English (preferable for sites where English is not the first language).
7. Ability and availability to work in shift patterns, as required by business needs.
8. Computer literate with knowledge of the MS Office package.
9. Must have the Knowledge, Experience and Skills to conduct tasks in accordance with the rules and procedures set down.
Please note that if you are NOT a passport holder of the country for the vacancy you might need a work permit.
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