QC Analyst - IPC

Hiring Request Post Information* : Posted Date 4 months ago(2022/11/16 14:43)
ID
2022-8892
# of Openings
1
Job Locations
IE-Cork
Job Family
QUALITY

Join a Market Leader

Hovione is an independent family owned international group of companies. From the beginning, we have set ourselves above and apart through our innovative technological and productive capabilities, reaching a top spot in the world market as an integrated Contract Development and Manufacturing Company dedicated to helping Pharmaceutical Customers bring new and off-patent drugs to market.

 

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:

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. Manage and control all Quality Control activities in accordance with identified quality assurance standards, company procedures, client specifications, contract requirements, and regulatory guidelines.

 

This is a 4 cycle shift based role within our In-Process Control Team.

 

  • To organize and define daily priorities within their assigned tasks in order to accurately and promptly perform the allocated sample analysis to meet the requirements of the periodic laboratory plan and area KPIs.
  • To adhere to the laboratory testing schedule in order to achieve an efficient Quality Control (QC) system.
  • Take responsibility for all data individually generated and ensure it is in accordance with all applicable GMP requirements and HSE regulations, adhering to all relevant Operating Procedures and industry standards in conducting all analytical activities.
  • To maintain all checklists, laboratory records and notebooks in which he/she is involved to an acceptable GMP standard and in accordance with Hovione internal procedures.
  • To perform routine calibration and both corrective and preventative maintenance of designated laboratory instruments, requesting any instrument parts and consumables required by the area.
  • To bring any discrepancies, deviations or non-conformance in testing or work practice to the attention of QC management in accordance with Hovione internal procedures.
  • To 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 department in relation to QC work by using the appropriate Hovione processes and their IT platforms.
  • Assist with audits as required, following the instruction of QC Management.
  • Undertake any additional tasks to support the laboratory activities as and when required.
  • Follow all annual performance review requirements, including completion of the self-assessment.
  • Carry out assigned tasks and duties in a safe manner, in accordance with instructions, and to 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.

We are looking to recruit a Candidate:

  • Qualification in a relevant chemistry, analytical chemistry, chemical engineering, pharmaceutical-related or other science-related field.
  • 3 years + experience of GMP practices and HSE standards
  • Experience in HPLC, GC, KF, Particle Size, Investigaton & troubleshooting, GMP, Empower, LIMS etc are all highly desirable  
  • Previous shift experience is not essential 
  • Proven practical pharmaceutical or related industry experience in a GMP regulated QC laboratory environment is mandatory
  • Clear and open communication skills (written and verbal)
  • Fluent (written and verbal) English

 

Hovione is a proud Equal Opportunity Employer

 

Inclusion and diversity are key to us. At Hovione, that means a work environment where differences are valued, and everyone is treated with fairness and respect. We want all our team members worldwide to feel supported, respected, and have the opportunity to achieve their full potential, regardless of their age, gender, religion, disability, sexual orientation or ethnicity.

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