Senior QC Analyst
About Chanelle Pharma:
Chanelle Pharma is Ireland’s largest indigenous generic pharmaceutical manufacturer of both medical and veterinary products.
Serving customers in 96 countries worldwide, Chanelle Pharma is a partner of choice in the development and manufacturing of pharmaceutical products to the world’s leading human generic and animal health multinationals and distributors. We are passionate about understanding and addressing the challenges facing our medical and veterinary customers and bringing them innovative and effective products and solutions.
This role involves conducting 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. It also involves providing technical support as required by management. In this role you will report to the Quality Control Supervisor/Manager.
- 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 of 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.
- Any other duties as assigned by the QC team leader/supervisor or manager.
- Bachelor’s degree in a science-based discipline with a minimum of 10 years’ experience in a pharmaceutical manufacturing environment.
- Displays key behaviours such as:
- Establishes strong working relationships with others, building team rapport and creating a cohesive team environment.
- 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.
- Health & Safety requirements (eg. Manual Handling Training).
- To take reasonable care for their own safety, health and welfare at work and that of any other person that may be affected by their acts or omissions while at work.
- Adheres to safety regulations by ensuring correct usage of PPE in the lab area.
- Reports to the supervisor or health and safety representative without unreasonable delay any defects in plant, equipment, place of work, system of work which might endanger safety, health or welfare of themselves or any employee, contractor or visitor to the company.
- Not to intentionally or reckless interfere with or misuse any appliance, protective clothing, convenience, equipment or other means or thing provided.
- Manual Handling training.
- Glove removal and disposal training.
- Working with chemicals.
- Disposal of waste.
- Working on PC.