QA Specialist & Responsible Person

Acorn Regulatory’s ongoing growth has created an interesting opportunity for a full-time QA Specialist and Responsible Person. The post, which is based in our Clonmel office but allows for remote work, requires a B.Sc. in a Life Science subject and 5+ years of Quality and GDP expertise, including RP responsibilities.

Job Title: QA Specialist & Responsible Person

Location: Flexibility to work remotely and occasionally at Acorn Regulatory’s main office located in Clonmel, Co. Tipperary

Contract Type:  Permanent. Full Time (39 hour working week)

Attributes/Experience required:

·      B.Sc. in a Life Science related discipline as minimum

·      Minimum of 5 years’ experience in Quality and GDP

·      At least one year’s experience named as an RP on a wholesale distribution authorization

·      Significant experience named as a Deputy RP on a wholesale distribution authorization

·      Thorough knowledge of GDP requirements

·      Ability to represent clients across different levels of the organization, including dealing with competent authorities

·      Experience and comprehensive knowledge of ISO 9001 standard, GMP and GDP Guidelines

·      Experience performing audits would be an advantage

·      Strong interpersonal and communication skills with proven ability to influence people both internally and externally to achieve objectives.

·      Ability to project manage and multi-task workload

·      Excellent attention to detail, with client satisfaction an integral part of your work ethic

·      Maintain client confidentiality and observe discretion at all times

·      Strong work ethic

Key Accountabilities/Responsibilities:

 1.       Support the Quality team with the maintenance of the company’s QMS;

2.       Ensuring compliance to ISO 9001 and GMP requirements and internal procedures;

3.       Managing the internal QMS such as raising non-conformances,  change controls, CAPAs, quality complaints etc.  as required

4.       Maintenance of the supplier controls system, including completion of supplier evaluations, assessment and repeat evaluations according to internal procedures;

5.       Ensuring compliance to Internal Audit schedules, executing internal audits;

6.       Ensuring continual improvement, maintenance of internal KPIs and updates as deemed appropriate;

7.       Liaising with fellow team members and ensuring awareness to changes to QMS as appropriate.

Specific to role of Responsible Person for nominated clients:

 1.       Ensure compliance with the requirements of GDP and other relevant guidelines including EU GDP guidelines, HPRA & UK (MHRA) requirements

2.       Ensure the safety, quality and traceability of products are maintained through the supply chain

3.       Ensure that the conditions of the Wholesale Distribution Authorisation are met and that all medicinal products wholesaled, are received, stored, transported, and delivered under strict GDP conditions

4.       Ensure that all bona fides of suppliers / customers are conducted and maintained in a timely manner

5.       Ensure self-inspections and audits are carried out as per written audit schedule

6.       Act as the main point of contact and be legally responsible to the HPRA and advise HPRA of any changes in a timely manner for those WDA’s where you are the nominated RP

7.       Lead regular management review meetings with Senior management teams

8.       Coaching/Mentoring Quality professionals/Deputy RPs

9.       Ensure patient safety and product safety at all times