Our client, a Pharmaceutical Manufacturing company in Galway is currently looking to recruit a QC Compliance for their site.
To provide technical expertise to assist in the 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 support as required to the QC laboratory supervisor
Essential Duties and Responsibilities:
- Generation, review & approval of 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.
- Calibration and maintenance of laboratory equipment as per calibration procedures & liaison with service engineers as required.
- Checking analytical results and approval of raw materials, finished product & packaging materials.
- To support the laboratory testing schedule in order to achieve an efficient QC system and Customer Service level of >95%.
- Maintain and follow all relevant Standard Operating Procedures (SOP’s).
- Timely Review and maintain all laboratory logbooks, notebooks & associated documentation to GLP.
- 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, ECPs etc.) as and when appropriate
- Participating in internal/external audits of the QC function.
- 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 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.
- Establishes strong working relationships with others, building team rapport and creating a cohesive
- Displays a positive outlook with strong coaching skills, maintaining interest at all times
- 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
- Escalates issues appropriately
- Takes action to correct poor performance by being fair and consistent in approach
- Displays flexibility, willingness to succeed and goes the extra mile
- Any other duties as assigned by the QC team leader/supervisor or manager.
- If decided appropriate it may be decided to amend / update any of the above responsibilities.
- Experience working in a manufacturing environment, preferably pharmaceutical
- Proficiency in Microsoft packages to include (MS Word, Excel, Outlook) essential
- Systems experience desirable
- Excellent attention to detail
- A self-starter with excellent motivational and problem solving skills
- Good communication and inter-personal & collaboration skills
- Flexible and able to adapt to new responsibilities and challenges
For further information on this QC Compliance role in Galway please contact Anna on 086 8168298 / firstname.lastname@example.org
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