Our client, a Medical Device company in Galway is currently looking to recruit an Senior QC Analyst for their site.
- To carry out analytical testing on finished product & raw materials using the correct procedures in order to comply with GMP, Health and Safety, SOP’s and environmental and regulatory requirements while ensuring we meet our customer’s needs.
- To provide technical support as required by management
Essential Duties And Responsibilities:
- Maintain and follow all relevant Standard Operating Procedures (SOP’s).
- Adherence to the existing methods with reference to pharmacopoeia’s, specifications, regulations and industry standards.
- Displays technical competency and full understanding of methods and equipment relating to the following areas: HPLC, IR, UV, dissolution & physical testing.
- Full analysis raw materials in a timely manner using appropriate analytical techniques with limited analyst related OOS
- Full analysis of finished product (tablets, boluses, veterinary drenches etc) in a timely manner using appropriate analytical techniques with limited analyst related OOS
- Full analysis of contract manufactured products in accordance with customer specifications with limited analyst related OOS
- Completion of method transfer analysis and protocols
- Completion of cleaning validation analysis and protocols
- Checking analytical results and approval of material
- Scheduling of finished product analysis for the finished product group
- Calibration and maintenance of laboratory equipment as per calibration procedures
- Training of new personnel in the receipt and analysis of finished product
- Displays ability to troubleshoot, supporting analyst’s/trainee’s with methods and equipment
- To support the laboratory testing schedule in order to achieve an efficient QC system and Customer Service level of <95%
- Review and maintain all laboratory logbooks, notebooks & associated documentation to GLP
- Liaise with team leader/supervisor & production so that timely reporting of results is achieved
- Ensure timely feedback of all queries as appropriate.
- To bring to the notice of the team leader/supervisor any discrepancies, deviations or non conformances in testing or work practice
- To complete OOS investigations and follow up on corrective actions
- Amendment of lab procedures (SOP’s, FPP’s) as and when appropriate
- Liaising with production so that materials are approved in a timely manner in accordance with their requirements
- Ensuring that there are adequate retains samples of any product you have analysed
- Sending out samples for external analysis when requested
- Cost effective budget adherence, proactively looking for ways to reduce cost
- Participating in internal/External Audits
- Liaising with external suppliers/vendors in relation to QC consumables
- Ensuring that existing quality procedures are followed in all areas and where appropriate suggestions/change control forms prepared such that the quality system can be improved
- To adhere to any agreed internal laboratory rota tasks
- To encourage and maintain good housekeeping and hygiene within the laboratory
- To proactively create and encourage a safe working environment, adhering to laboratory safety measures at all times
- Lead by example ensuring that your work area is kept tidy and that GLP/GMP standards are adhered to at all times
- Ensure records pertaining QC are all kept up to date and filed properly.
- Degree in Science Discipline or equivalent.
- Minimum of 3+ years experience within the pharmaceutical industry.
- Experience in HPLC essential
- Takes a methodical, systematic and structured approach to organising work
- Makes effective and consistent decisions in a timely manner
- Takes personal responsibility for making a decision, taking action within their own area
- Displays flexibility, willingness to succeed and goes the extra mile
For further information on this Senior QC Analyst role in Galway please contact Anna on 086 8168298 / firstname.lastname@example.org
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