Quality PRRC Manager - Medical Devices
- Employer
- Thornshaw Recruitment
- Location
- Dublin (County), Leinster (IE)
- Salary
- Negotiable depending on experience
- Start date
- 25 May 2023
- Closing date
- 7 Jun 2023
View more
- Discipline
- Quality
- Hours
- Full Time
- Contract Type
- Permanent
- Experience Level
- Management
Job Details
Quality & PRRC Manager
My client a global pharmaceutical/ medical device company is currently recruiting for a Quality PRRC Manager to join their team.
- Permanent position Hybrid working available. Reporting to: Director of Irish entities of the company
Job Profile:
To manage, support and ensure effective implementation of all operational activities related to the QMS for the Irish entities of the company. To be the person responsible for regulatory compliance (PRRC) and responsible person (RP) for the Irish entities of the company. Ensure compliance with MDR 2017/745, ISO 13485, 21CFR Part 820, Good Distribution Practice (GDP 2013/C 343/01) and Health Products Regulatory Authority (HPRA) guidelines and all applicable quality regulations, directives, standards, guidelines and best practices applicable to the Irish entities of the company.
Ensure that the systems and processes in place are adhered to and that procedures and appropriate training is in place and maintained up-to-date within the company, covering all MDR and GDP activities
Main responsibilities and duties:
Medical Devices responsibilities include:
- Perfom the role of person responsible for regulatory compliance (PRRC) for medical device products distributed by the Irish entities of the company Maintaining the Quality Management System comprised of ETQ (document management system) documentation associated with company procedures ensuring audit-readiness at all times Handling complaints and processing post-marketing requirements for medical devices within the specified timelines ensuring that the company complies with post-market survelliance and reporting obligiations Conducting corrective and preventative actions, updating the CAPA log and reporting the progress of the CAPA at scheduled quality and annual management review meetings Supporting on-site audits of critical suppliers Handling and maintain documentation supporting MDR and ISO standards Creation of new SOPs and other quality documents Carrying out risk assessments and managing change controls Oranising, managing and monitoring training via ETQ and maintaining training files Completing final batch release approval including checks on batch documentation recevied from CMO
GDP responsibilities include:
- Perform the role of responsible person (RP) for pharmaceutical products distributed by the Irish entities of the company
- Ensure compliance with relevant Wholesale Distribution Authorisations, EU GDP Guidelines 2013/C 343/01 and relevant Health Products Regulatory Authority (HPRA) Guidelines, legal requirements and updates.
- Ensure compliance with the requirements of GDP guidelines both EU and HPRA
- Ensure the Quality System is implemented and maintained. RP must approve, sign and date, all GDP SOPs/Documentation
- Annual reviews of SOPs/Documentation must be carried out and documented
- Ensure that the conditions of the Wholesale Distribution Authorisation are met and that all medicinal products handled, are received, stored, transported and delivered under strict GDP conditions.
- Bona Fides
- Supplier/customer approval by ensuring initial Bona Fides are established and maintained annually (every 365 days), for all relevant suppliers and customers in advance of product receipt or supply and sign off by the RP.
- The RP will ensure copies of all wholesale/manufacturing authorisations, certificates of GDP/GMP compliance are obtained (if available), and reviewed, in place, valid and maintained in the English language.
- Ensure that only the relevant product classes procured from approved suppliers and supplied to approved customers are covered under its Wholesale Distribution Authorisation.
- Retain all GDP records for at least 5 years.
- Document the procedures relating to: -
- any impact on product quality
- goods procured and supplied
- bona fides, traceability
- quarantine/status of products/disposal
- complaint management
- falsified medicines
- self-Inspection
- returns/recall
- change control
- deviation / CAPA management
- risk management
- Management review
- Ensure that all staff procuring and supplying medicinal products (including narcotics or psychotropic products) are trained in GDP and the specific SOPs so they can operate competently in the GDP duties assigned to them. All training must be properly recorded and reviewed by RP. GDP training must be both initial and ongoing (every 365 days).
- Ensure that the relevant proposed/approved premises is fit for the purpose of storing GDP records for at least 5 years.
- Be the decision maker on all relevant non-conformances and corrective, preventative actions and complaint management/customer service.
- Act as the main point of contact with the HPRA and advise HPRA of any changes to facilities or changes to RP, product changes in a timely fashion.
- Ensure communication takes place with Marketing Authorisation Holder (MAH) when required.
- Ensure that any additional applicable legal requirements are strictly adhered to (Article 83 of Directive 2001/83/EC)
-
- Bachelor’s degree in science or related fields or advanced science degree such as MS, MD, PharmD, PhD
- At least 10 years experience working with quality systems within the pharmaceutical and medical device industry with at least 5 years in a similar senior position Must have PRRC experience and ideally will also have fulfilled an RP role Prior people management experience is required Experience dealing with notified bodies is a requirement Knowledge and experience with MDR 2017/745, ISO 13485, 21CFR Part 820, GDP, GMP and GCP and all applicable quality regulations Excellent communication and interpersonal skills Strong planning and organisation skills
Company
Thornshaw Scientific Recruitment was first established in 1999 and since then has become a leader in Scientific recruitment. In 2005 we partnered with Cpl Resources, one of Europe’s most successful recruitment companies.
Our wealth of experience in specialised recruitment allows us to offer the right solution to each employer, whatever their recruitment requirements.
Over the years we have developed strong relationships with our clients in the market and we pride ourselves on our repeat business from clients.
Our Industries
We are a global provider and have been providing a reputable recruitment service to the Biotech, Pharmaceutical, Clinical Research, Medical Device, Engineering and Healthcare industries for over 20 years.
Our Specialities
Clinical Research, Regulatory Affairs, Quality Assurance, Medical Affairs, Pharmacovigilance, Biostatistics, QC, Validation.
Our Mission
For further details on our services contact Tina at +353 1 2784701 or email tdunne@thornshaw.com
- Website
- http://www.thornshaw.com/
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