Responsible Person/Control Drug Officer (12 month Contract)

Oranmore

BASIC SUMMARY:
The role of a Responsible Person/Control Drugs Officer involves the management of the entire QMS, RP Duties including GDP and Controlled Drugs procedures within the Chanelle Oranmore and Ballinasloe Distribution business. This individual is accountable for making decisions, managing resources, and ensuring that objectives are met efficiently and effectively. The Responsible Person/ Control Drugs Officer primary responsibility is the successful implantation and on going compliance in all areas of the Chanelle Distribution QMS
The following Job Specifications sets out the Key Responsibilities, Competencies for the Responsible Person/Control Drugs Officer, here in now referred to a RP/CDO

In this role you will report into the Head of Animal Health Ireland in terms of day-to-day management, performance setting and assessment. The role will also work closely and report operationally into the Qualified Person/Vendor Manager in terms of technical support, escalation point and governance oversight for the RP role.

KEY RESPONSIBILITIES:
• Development, Implementation and Maintenance of QMS within Chanelle Distribution
• To Ensure Operating procedures in place, and on-going assessment of such controls, in order to
maintain security, accountability and reconciliation for all Vet products.
• Ensuring All operating procedures relating to QMS, are followed, reviewed and that required training is given to relevant staff.
• The RP/CDO is responsible for safeguarding product users against potential hazards arising from poor distribution practices
• The RP/CDO should fulfil their responsibilities personally and should be continuously contactable. The RP/CDO may delegate duties but not responsibilities.
• The RP/CDO, if not available, must delegate duties to the deputy RP so that continuity of business is ensured.
• Procedures should describe all distribution activities that affect the Identity, traceability and quality of the veterinary medicinal product.
• Responsible for implementing a formal process review of the quality system on a periodic basis to the Senior Management Team.
• Ensuring that initial and continuous training programmes are implemented and maintained.
• Coordinating and promptly performing any recall operations for veterinary products
• Ensuring that relevant customer complaints are dealt with effectively.
• Ensuring that suppliers and customers are approved.
• Approving any subcontracted activities which may impact on GDP.
• Ensuring that self-inspections are performed at appropriate regular intervals following a prearranged programme and necessary CAPAs are put in place.
• Keeping appropriate records of any delegated duties.
• Deciding on the final disposition of returned, rejected, recalled or falsified products.
• Approving any returns to saleable stock.
• Ensuring that any additional requirements imposed on certain products by national law are adhered to.
• Documenting deviations and deciding on CAPAs to correct deviations and avoid their reoccurrence and monitoring the effectiveness of those CAPA’s
• Establish appropriate procedures relating to personal hygiene, including personal health and
appropriate clothing relevant to the activities carried out.
• Ensure that the premises shall be designed and appropriate in order to ensure the required storage conditions for all products including controlled drugs.
• Temperature monitoring to be in place in all required warehouses and associated documentation to be maintained.
• Responsible for all equipment used in the storage and distribution of veterinary products that they are designed, located and maintained to a standard suitable for its purpose.
• To ensure they are continuously trained in all areas of Veterinary/CD legislation and that adequate training is completed with all required staff.
• Under the responsibility of the Control Drugs Officer, this role is responsible for the management of all operating procedures in relation to controlled drugs.

COMPETENCIES:

• Knowledge of the European GDP Guidelines.
• A strong knowledge of all GDP and relevant legislation
• Demonstrate an ability to implement a Quality Management System and all relevant SOP’s.
• Organizational skills, personal efficiency, time management skills and the ability to priorities
competing demands are key communication skills.
• Ability to deal with diverse personalities and viewpoints.
• The ability to build relationships and collaborate with others is vital.
• Strategic decision-making within the business as an influencer.
• Demonstrate and lead on the values, initiatives, and culture of an organization. Professional
expertise.
• A strong working knowledge of best practice processes.
• Demonstrated ability in prioritizing key initiatives, driving growth and setting targets and
KPIs to monitor performance.
• Positive and proactive person who is energized by having great responsibility.
• The above is not intended to be construed as an exhaustive list of all responsibilities, duties
and skills required.

QUALIFICATIONS:
• Qualified as a Responsible Person (RP) in accordance with GDP, EU and HPRA requirements
• Bachelors/master’s in quality or Pharmaceutical Science disciplines essential
• Minimum 3-5 years’ experience working as a RP/Controlled Drugs Officer in the pharma/veterinary or medical distribution business essential
• People management skills are critical as the role will be accountable for managing the performance of a Deputy RP and lead others to deliver results
• Detailed knowledge and experience creating and maintaining a Quality Management System (QMS) compliant with GDP, with a focus on compliance and continual improvement.
• Excellent computer skills: word, excel, typing.
• Excellent written and communication skills

PHYSICAL DEMANDS: Health & Safety requirements:
V.D.U
Manual Handling

WORK ENVIRONMENT:
Office

Responsible Person – GDP (12 month Contract)

Reference No: J0742
Galway