(Dublin) Senior Quality Specialist & Deputy Responsible Person – Aspen Pharmacare

In the absence of the Responsible Person (RP), the Senior Specialist/ Deputy Responsible Person (DRP) shall partner with the Operations Team and the MA holder to assist and participate in the assurance of compliance activities required to ensure that products supplied by Aspen are in accordance with cGMP/GDP and their associated Marketing Authorisation, Aspen standards and values.

The Senior Specialist / Deputy Responsible Person is responsible for supporting the RP in carrying out his/her duties and to fulfil the duties of the RP in the event of the RP’s absence, or as justified and detailed by the RP.

Responsibilities:

• Is responsible for ensuring the conditions of the APIL Wholesale Distribution Authorisation are complied with and that the APIL wholesale and distribution activities comply with current legislative requirements including EU Good Pharmaceutical Distribution Practice and guidance from the HPRA.
• Shall act and perform duties under the provisions of APIL’s Wholesale Distribution Authorisation
• Shall ensure the conditions of the WDA are maintained and provide recommendations to APIL senior management on where APIL could improve its compliance with GDP.
• Shall advise APIL senior management on Good Distribution Practice (GDP), outlining where APIL may not be following GDP and providing recommendations to ensure compliance with GDP.
• Shall ensure that APIL operations don’t compromise the quality of medicines by ensuring that secure systems are in place throughout the supply chain under the control of APIL.
• Shall ensure that any additional requirements imposed on certain products by national law are adhered to, as foreseen in Article 83 of Directive 2001/83/EC.
• Shall be contactable by the HPRA, the Competent Authority at all times and provide the HPRA with the appropriate contact details. (In situations where the RP is not available the Deputy RP shall be available and their contact details shall also be provided to the HPRA).
• Shall ensure that there is an adequate Quality Management System (QMS) in place and that it’s maintained in compliance with GXP requirements
• Shall ensure Standard Operating Procedures and all master quality documents
• Shall ensure change proposals and action plans are approved
• Shall conduct and oversee internal and external audits.
• Shall ensure that all personnel are trained, that continuous training programmes are maintained.
• Shall ensure any subcontracted activities which may impact on GDP as per SOP are approved and that suppliers and customers are approved.
• Shall assist the Marketing Authorisation Holder (MAH), following a decision to recall a product for which MAH is the product.
• Shall ensure that customer complaints are dealt with efficiently and effectively
• Shall ensure that Quality Technical Agreements and Service Agreements are in place with all contractors and service providers
• Shall ensure that all the records created in relation to GXP are stored in a secure location and are available/retrievable.
• Assist and/or manage HPRA inspections and internal audits.
• Shall decide on the final disposition of returned, rejected, recalled or falsified products
• Shall have sufficient knowledge on the products APIL distributes and on the complexity of the operation. (The RP shall keep themselves up to date with any changes in the legislation and with on-going training as identified.)

Requirements

• BSc in Science
• 5+ years of experience in the Pharmaceutical industry
• 5+ years of experience in Quality Assurance and Risk Management
• Experience in Regulatory compliance (desirable)
• Experience in GDP Warehouse (desirable)
• Experience in Supply Chain (desirable)

Benefits:

• Flexible working hours
• Bonus scheme
• Work from home opportunities
• Sick pay
• Company events & social hours
• Private medical/dental insurance
• Wellness programmes
• Company pension

Work Level

Senior

Job Type

Permanent

Salary

Market Related

EE Position

No

Location

Dublin