Description:
Responsible for providing quality support within the warehouse / distribution / manufacturing operations at United Drug – Goods Receipt, Stock Disposition, Returns, New Product Introduction, Complaints Management, FMD support – in addition to reviewing quality standard for house-keeping, pest control and GDP documentation within the warehouse (s). The role is based in Magna Park but may require travel to other United Drug sites.
Key Duties
- Conduct Quality Inspections of incoming goods to ensure compliance with specified plans including: Temperature review, Artwork inspections, Exempt checks, Controlled Drugs licence activities, FMD activities.
- Co-ordinate the release of the goods with the Principal in a timely manner according to GDP.
- Collaborate with Operations to drive Quality awareness, facilitate GDP and implement improvements.
- Ensure that appropriate SOPs and Work Instructions are generated and maintained.
- Responsible for disposition of product (Quarantine and Release) using SAP
- Responsible for generation and provision of the Controlled Drugs report to external bodies
- Support the setup processes for new products, vendors and customers at United Drug
- Establish and regularly review vendor and customer Bona-Fides including management of principal specific orders
- Communicate deviations to GDP standards and document investigations into root cause in order to identify appropriate CAPA
- Manage the product Quality Defects / Adverse Events report to MAH, Supplier and Regulatory Authorities
- Utilise a continuous improvement approach in all aspects of role
- Participate in customer and regulatory audits to assure compliance to GDP.
- Perform regular review of the Pest Control programme at UD
- Perform sampling activities and / or in-process checks as described in each Batch Record Instruction (PPS)
- Create inbound inspection plans and update product master records
- Provide support to operations teams as part of FMD
- Liaise with KAM’s and directly with Principals in relation to stock availability.
Other Duties Not Identified Above May Be Required
- Qualifications / Experience Required
- Relevant experience (2yrs +) working in the pharmaceutical or regulated distribution industry or other combination of experience and educational background that may otherwise satisfy the requirements of the role.
- Life Science diploma or degree in a related discipline preferred.
- Working knowledge of SAP in particular QM Module and Master Data.
- Detailed Knowledge of applicable Regulatory requirements including working knowledge of current Good Distribution Practice (GDP)
- Demonstrates good verbal, written, and interpersonal communication skills.
- Strong organizational skills, including ability to follow assignments through to completion
- Demonstrated ability in problem solving and experience in managing Root Cause Analysis / Non Conformance /Deviation investigations preferred.
- Attention to detail and good follow through with a high level of accuracy
- Ability to work towards deadlines
- Strong focus on customer needs and customer service.
- Awareness of Health & safety and GDP requirements.
- Ability to plan effectively is essential for this role
- Strong Analytical Skills
- Ability to work both independently and as part of a team