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 is an opportunity to be part of a dynamic team within the Quality Control department. We are looking for individuals who will support and drive Chanelle Pharma’s vision to be the most valued global provider of high quality, competitively priced pharmaceutical products and to provide excellent services and support to our customers.
You will provide guidance, support, coaching and mentoring to Stability Teams in carrying out analytical testing ensuring the correct procedures are adhered to in order to comply with GMP, Health and Safety, SOP’s and environmental and regulatory requirements while ensuring we meet our customer’s needs.
You will be responsible for the day to day supervision of the stability group and analysis.
You will also provide technical support as required by management. You will liase with customers and Health Authorities when required.
In this role you will report into the Head of Quality.
- Co-ordinate and manage the on site stability programme at CPML
- Co-ordinate the stability programme in Chanelle Lab Jordan relating to the CPML site
- Liaising with customers as the need arises
- Assisting in internal and external audits
- Problem solving and team management
- Responsible for putting corrective actions in place and ensuring ongoing compliance with customer specifications and Chanelle QMS
- Assessing and delivering product specifications and customer requirements
- Actively promote best practice in quality methods and continuous improvement
- Ensure all process documentation is fully auditable i.e. that it is prepared, updated and filed in accordance with all Regulatory guidelines
- Provide project leadership to ensure effective planning and timely execution of all process improvements
- Provide technical advice and support to other departments in relation to investigations
- Update of site quality system with recommendations for improvement where appropriate
- Ensure adherence to all relevant Standard Operating Procedures (SOP’s), Calibration and Operation Instructions (COI’s) and existing test methods with reference to pharmacopoeia’s, specifications, regulations and industry standards
- Scheduling of stability analysis, prioritising work in consultation with quality, production and planning in order to achieve an efficient QC/stability system
- Ensure full analysis of finished product and contract manufactured products are performed in a timely manner and in accordance with approved test methods, schedules and customer requirements
- Ensure stability testing, method transfer and protocols are accurately completed on a timely basis as per GMP/ICH guidelines
- Ensure product requiring external analysis is accurately documented, despatched and a certificate of analysis received in a timely manner
- On-going monitoring of external laboratories
- Approval of analytical reports, obtaining and reviewing certificates of analysis (where appropriate) and approval of material
- Ensure trend analysis is completed as per GMP requirements
- Ensure stability protocols and reports are completed as per GMP requirements in a timely manner
- To bring to the attention of the Head of Quality any discrepancies, deviations, OOS, OOT or non conformances in testing or work practice
- Ensure completion of OOS investigations, follow up and implement corrective actions in a timely manner
- Monitoring of OOS and deviations for trend development, highlighting and implementing areas for improvement
- Display proven ability in troubleshooting and problem solving, supporting analysts/trainees
- Selection and recruitment of QC analytical staff in conjunction with QC Manager/HR
- Training of new personnel in the receipt and analysis of finished product/stability samples, ensuring all personnel are fully trained prior to analysis
- Ensure a training plan is prepared for each member of the Stability group and training records are maintained and kept up to date at all times
- Review all laboratory notebooks, records, chromatograms etc. to an acceptable GLP standard and up to date at all times
- Liaising with other team leaders/supervisor/manager and production such that timely feedback of all queries, reporting of results and approval of product is achieved in accordance with their requirements
- Review and update of existing quality procedures/systems while also highlighting, preparing and implementing new quality procedures/systems such that the quality system can be continuously improved
- Ensure records pertaining to Stability are all kept up to date and filed
- Performance monitoring of the Stability staff
- Benchmarking of the company’s technical capability against external best practice
- Any other duties as assigned by the Head of Quality
If decided appropriate it may be decided to amend / update any of the above responsibilities.
- 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 and find solutions
- Takes action to correct poor performance by being fair and consistent in approach
- Displays flexibility, willingness to succeed and goes the extra mile
Degree in Science or Equivalent scientific qualification
PHYSICAL DEMANDS: 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.
- To cooperate with Chanelle or any of its representatives that will enable the company to comply with the relevant health and safety statutory provisions.
- 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.
- Keeps work area safe, clean and tidy
- Not too 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
WORK ENVIRONMENT: (e.g. Office, Production)