QA Inspector - Weekend Shift
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 function. 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.
In this role, you will be tasked with ensuring all products and documentation comply with GMP and regulatory requirements for Realoch Pharma.
· Approves incoming materials by confirming specifications; conducting visual and measurement tests; rejecting and returning unacceptable materials
· For all products manufactured and or packaged by Realoch Pharma to carry out finished goods/end of line inspection prior to product release and shipment.
· To follow through on any corrective actions or deviations raised against particular batches and to trend deviations at appropriate intervals.
· For all products manufactured and or/packaged by Realoch Pharma to ensure the sufficient retains are sampled, labelled and stored correctly.
· To ensure that all retains are stored and organised in such a way that allows them to be easily accessed.
· To ensure that all manufacturing, packaging and analytical documentation is scanned, filed and stored correctly in such a way that any batch related documentation can be easily accessed.
· Ensure compliance with current GMP and to assist with training in same.
· To inspect and approve printed and non-printed packaging where required setting up master packaging samples.
· Inspects materials following set procedures
· Develop master samples and file in orderly fashion.
· Labelling of approved and rejected materials.
· Where necessary, raise supplier corrective actions for any non-conforming materials; help ensure these are closed out in a timely manner.
· To follow through on complaints raised against packaging suppliers
· Review of standard operation procedures and update where necessary.
· Keeps measurement equipment operating by following operating instructions; calling for repairs when necessary.
· Ensures all measuring equipment is fit for use and inside calibration.
· Calibration of incoming inspection equipment.
· Maintains a safe and healthy work environment by following standards and procedures; complying with legal regulations.
· To carry out other duties and undertake other responsibilities as may be assigned by the Quality Manager or his /her designate
- Organisational skills, personal efficiency, time management skills and the ability to prioritise competing demands.
- Excellent communication skills, both verbal & written.
- Ability to prioritise decision making differentiating between urgent and non-urgent.
- Ability to build relationships and collaborate with others.
- Maintains the highest standards of ethical behaviour. Escalates issues appropriately.
- Practical, action-orientated approach to managing priorities.
- Strong analytical ability and associated problem solving.
- Flexible and shows willingness to learn to develop technical skills.
- Takes a methodical, systematic and structured approach to organising work
- The above is not intended to be construed as an exhaustive list of all responsibilities, duties and skills required.
· Previous experience in a pharmaceutical / manufacturing environment.
· 2+ years’ experience in Quality Assurance / Documentation.
· Preferred Science qualification
· Excellent attention to detail.
· Good IT & Business Administration Skills.
· Good GMP & GDP knowledge and experience.
· Self-starter with demonstrated efficient work methods, and ability to handle multiple tasks