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 QA 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 report into the Senior QA Manager
Responsibility for batch release as per EU and US FDA guidelines by ensuring the following requirements have been met:
- the batch and its manufacture comply with the provisions of the marketing authorisation (including the requirements for importation where relevant);
- manufacture has been carried out in accordance with GMP (in the case of an imported batch that it has been manufactured to standards equivalent to EC GMP);
- the principal manufacturing and testing processes have been validated (account has been taken of the production conditions by review of the relevant documentation);
- any deviations or planned changes have been duly authorised. Any changes requiring variation to the marketing authorisation have been notified and authorised by the relevant authority.
- all the necessary checks and tests have been performed.
- all necessary production and Quality Control documentation has been completed and endorsed by the appropriate staff;
- Forward any incoming reports (whether it is through post, e-mail, fax or in Person) regarding Pharmacovigilance / Adverse Action Reports to the relevant QPPV in a timely manner.
- all audits have been carried out as required by the QA system;
- take into consideration any other relevant factor that may affect the quality of the batch.
- Overall Management of the supplier management programme within Chanelle Pharma.
- Review & Approval of New Vendors into the site
- Act as main point of contact for Vendor
- Report Non-conformances from Vendors in a timely manner
- Monitoring of all ASLs/ AMLs and ensuring compliance to same.
- Monitoring of supplier API Technical Agreements, Excipient and primary packing and printed packing materials.
- Establish and maintain records of supplier’s performance
- Vendor evaluation – evaluation of potential new suppliers/materials. Final overall assessment prior to approval, liaison with all relevant departments as a part of implementing change.
- Ensuring supply chain routes including manufacturer, brokers, agents, transport companies that maybe involved. Collation of relevant compliance documentation from same. Obtaining supply chain route validation where necessary.
- Ensuring storage and transport conditions for all materials and ensuring compliance.
- Management of Supplier risk assessment for excipients and Packing materials.
- Ensure all work carried out is in compliance with the required standards and all direct reports are trained to conform to Company policies and procedures.
- Preparation and Maintaining Audit schedules
- Maintaining Audit reports and follow up on CAPA plan from vendors.
- Providing support to QPs in preparation of QP declarations.
- Implement suggestions for improvement / development of the Quality System
- Create and Present monthly and quarterly metrics.
- Any other duties as assigned by the Head of Quality/ Senior QA Manager
- Organisational skills, personal efficiency, time management skills and the ability to prioritise competing demands are key communication skills.
- Ability to build relationships and collaborate with others is vital.
- Strategic decision-making within the business as an influencer.
- A strong working knowledge of best practice processes, change management implementation, coaching and mentoring.
- Demonstrated ability in prioritising key initiatives, driving growth and setting targets and KPIs to monitor the performance
- Positive and proactive person who is energized by having great responsibility.
- Practical, action-orientated approach to managing priorities and teams.
- Strong computer skills in MS Office
- A Bachelor’s degree in a Science related discipline.
- Desirable a minimum of 5+ years’ experience of working in a similar role in the Pharmaceutical Industry.
- Knowledge of EU quality-related pharmaceutical regulations.
PHYSICAL DEMANDS: Health & Safety requirements (eg. Manual Handling Training)
WORK ENVIRONMENT: (eg. Office, Production)