Responsible Person (Quality Assurance) Dublin N
- Logistics & Supply Chain Management
- Dublin North
- Dublin North
Responsible Person - Pharmaceutical Storage & Distribution.
To ensure that the conditions of the Wholesale Authorisation (WA), all EU Directives, Regulations and EU/HPRA Guidelines on GDP are complied with by the company and that a Quality System is implemented and maintained.
The RP has full responsibility for Medicinal Products and the operations under GDP from sourcing, receipt, and storage to final customer delivery with full traceability for all products throughout the Supply Chain managed by the company.
The company has given authority to the Responsible Person to perform the required activities as outlined in EU GDP Guidelines - Responsible Person (RP) responsibilities include but are not limited to:
- Ensuring that a quality management system is implemented and maintained
- Focusing on the management of authorised activities and the accuracy and quality of records
- Ensuring that initial and continuous training programmes are implemented and maintained;
- Coordinating and promptly performing any recall operations for medicinal 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 corrective measures 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
- To write, review and approve SOPs as required
- Reviewing and advising upon the company’s standard operating procedures in relation to the operation of the license
- Overseeing audit of the quality system on a regular basis, tracking and assisting in the closure of Internal and External Audits
- Implementation, execution and administration of CAPA’s as required
- Ensure that accurate records, as required by the individual elements of the QMS, are kept and maintained in a secure manner
- Assist the Supply Chain Organisation to ensure continuity of supply is maintained.
- Support ongoing integration projects associated with Distribution and Supply Chain
- The RP shall be involved, as required, in communications with the HPRA with respect to activities as they apply to the Wholesale Distribution Authorisation.
- Is accountable for all quality KPIs for the country or country cluster as required
- Contribute to develop and strengthen global quality management systems, and provide flexible support to business both at the country level and global level.
- Providing any other duties or giving such other advice properly associated with the duties of a Responsible Person under the terms of the License and Guidelines on Good Distribution Practice for medicinal product for human use (2013/C 343/01).
- Ensure appropriate notification to HPRA for products in scope of OCABR process and appropriate tracking of their release are in line with appropriate timelines.
- Qualification as responsible person for GDP (as applicable and required by country regulations)
- Bachelor’s Degree educated
- Practical experience of at least 5 years in the Pharmaceutical Industry, a majority of which has been gained in a QM / QA environment. Supply Chain knowledge is beneficial.
- Good knowledge of Pharmaceutical Quality Management systems
- Experience in handling inspections from local authorities
- Excellent knowledge of local GDP and Controlled Substances regulations, plus good awareness of other GMPGDP requirements e.g. ICH, FDA
- Experience of working with suppliers and customers
- Experience in working in a global and matrix environment
- Strong interpersonal skills including ability to build authentic relationships, constructively challenge conventional thinking, engender trust, cooperate as a team leader or team member, share information and deliver results with a team
- Execute goals and objectives in a driven and a high performance culture, and as applicable with ability to achieve results with non-direct reports
- Organization agility (knowledgeable about how an organization works) and ability to apply that capability to lead change, deliver strong results and build the confidence of stakeholdersAble to work with a great degree of autonomy, as part of a global virtual team
- Able to work cross-functionally and cross-culturally, in a global business environment
- Ability to manage multiple and complex priorities, and to recognize when a change of priority is needed
- Able to adapt to changes and positively respond to changes
- Enthusiastic, resilient, dynamic, versatile. Display 'Can do' attitude
- Good interpersonal and communication skills
- Excellent verbal and writing skills and fluent in English.
Terms: Permanent, Full-time
Package: Excellent package offered including Healtchcare, Pension & Bonus.
For a confidential discussion on this or any other current opportunity please contact Wesley Fitzgibbon on 01 8326330 / firstname.lastname@example.org
Please note that your application to this vacancy will be forwarded to all the consultants in The Logiskills Group as you may be suitable for other roles that we are unable to advertise.
You can follow our LinkedIn company page with up to date industry news as well as vacancy alerts athttps://www.linkedin.com/company/the-logiskills-group/
Please do not apply for this vacancy unless you meet the minimum pre-requisite requirements as our clients have instructed us that they do not wish to receive applications from candidates that do not meet the minimum requirements.
Logiskills are leading recruitment specialists for the manufacturing, freight & logistics industries. Roles we typically recruit for include; air, sea and road freight forwarding; warehouse; distribution; transport; logistics; supply chain; materials; purchasing; procurement; engineering; manufacturing; production; finance; accountant; customer service; admin; accounts; coordination; clerk; agent; supervisor; manager; management