Job description

DESIRED EXPERIENCE AND BACKGROUND OF THE SUCCESSFUL CANDIDATE

• MLO or HLO Bachelor degree in analytical chemistry (preferred) /pharmacy or equivalent experience. Preferably some years of experience in GMP.
• Knowledge and familiarity with the use of Pharmacopoeia methods
• A strong analytical oriented mindset.
• Experience with working in a pharmaceutical environment
• Experience with analytical routine testing
• Experience with analytical techniques like, UPLC/HPLC, TOC, PSD, etc.
• Good knowledge of Pharmaceutical quality systems and production processes
• Experience & exposure to work in regulatory environment as well as Regulatory Audit like EU cGMP inspection , US-FDA, ANVlSA.
• Team player.
• Strong can-do mentality.
• Results oriented.
  If you would like to have a confidential conversation regarding this opportunity please reach out to Tim Browaeys, tim.browaeys@orioneng.com or contact Tim on 0044 7593448607
  

  opportunity #multinational #pharmaceutical #quality #control #technician

Our role in supporting diversity and inclusion
As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment

WHAT WILL YOU DO

The Quality Control Analytical Laboratory is responsible for all analytical testing to support the production Cytotoxic and Inhalation drug products. The laboratory executes a wide variety of analytical test package to test APIs, excipients, packaging materials and drug products for release and stability purposes. Also transfer, validation and verification of analytical methods for testing of new drug products are performed in the laboratory.

MAIN RESPONSIBILITIES OF THE ROLE

• Routine Testing of the raw materials, primary and printed packaging materials & finished products, stability samples and in-process control samples according to SOP and as per the committed timelines.
• Handle quality management system like Deviations, Out of specification results (Phase 1 investigation), Out of trend results in stability as well as in released products.
• Writing, review and approval of test results.
• Maintain adherence to corporate policies and appropriate regulations through actions and decisions.
• Active participation in advanced problem solving, root cause analysis, troubleshooting, interpretation/consultation, verification of quality and test results discussions
• First line Troubleshooting of laboratory equipment.
• Active participation in changes or act as change owner as part of continuous improvement.