We are looking for an experienced QARA Manager and qualified Responsible Person (RP) in Ireland to ensure Good Distribution Practice (GDP) compliance in accordance with Regulation 45 of the Human Medicines Regulation 2021 and EU guidance on GDP (2013/C 343/01) and safeguarding product users against potential hazards arising from poor distribution practices and should be available on site and continuously contactable.
Location for the role is not yet determined but will be an hybrid role with 2 to 3 days in either Limerick or Louth area.
This key position will be responsible for meeting, strict timelines and protocols and building and maintaining positive relationships with management, peers, and other internal stakeholders and also covering the UK RP/RPi day to day activities during holidays.
Self-motivated and able to function effectively within team is essential.
Ambition: We play to win.
Focus: We put patients first.
Integrity: We keep our promises.
Openness: We are passionate about new ideas.
Respect: We support each other.
Your key responsibilities will be:
- Perform duties of RP as required by EU guidance and local regional legislation and maintains the Wholesale Distribution Authorisation.
- Responsible for the operation and continuous improvement of the Product Quality Management System (QMS) based on EU Quality standards and local regulatory requirements
- Maintenance of the Product Quality SOP system.
- Communicate new policies and legal requirements with respect to GDP issued by the relevant local health authority that could impact the business to the Senior RAQA Manager & RP and relevant stakeholders.
- Responsible for the change management and deviation system and manage all product quality issues (including product complaints) ensuring they are investigated, documented and appropriate CAPA is identified.
- Co-ordinate with manufacturers and promptly performing any recall operations.
- Training of the relevant personnel on Product Quality SOPs and processes.
- Apply Quality Risk Management
- To Ensure all suppliers and customers are approved as per the procedures.
- Measurement of performance indicators and management review
- Quality oversight and review of distribution activities, (including physician samples) and promotional material that has the potential to impact product quality or patient safety
- Ensure a self-inspection program is in place and inspections are carried out at appropriate regular intervals.
- Ensure appropriate external third - party oversight by performing assessments, monitoring performance and quality governance in compliance with Global Quality Standards.
- Support new product launches.
- Verify that every single batch distributed in EU is EU-QP certified.
- Ensure the appropriate communication to the local health authority of any reportable event related to product quality and product shortages.
- Always keep the Affiliate inspection ready
- Ensures oversight and governance of distribution third parties and maintenance of third-party quality agreements.
- Support the Quality team in the resolution of product quality related issues
- Support the Quality team for Regulatory audits.
- Support day to day activities while UK RP is out of office
- Degree level education in Pharmacy, Chemistry, Microbiology or Engineering or equivalent
- 3-5 years practical experience in handling, storage and distribution of medicinal products and transactions in or selling or procuring medicinal products with previous experience as Responsible Person (RP)
- Experience in implementation of a Quality Management System
- In-depth knowledge and experience with GDP regulation - Knowledge of the role of the MHRA & HPRA in the licensing of medicines’,
- Knowledge of relevant UK, IE & EU legislation
- Strong interpersonal and negotiation skills
- High attention to detail and accuracy
- Knowledge of the principles and practices of computer applications including word processing, spreadsheet, database management, and presentation software and internet search engines
- Excellent written and verbal skills
- Strong analytical and problem-solving skills.
- Attention to detail and the flexibility to adapt quickly to changing regulations.
- Must work effectively as part of team with strong collaboration
- Experience within the Ophthalmology sector
- Experience with MHRA Good Distribution Practices
- Experience in GMP regulation and industry standards (USP, Ph.Eur., ICH, FDA, EU guidance)
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