Quality Associate (RP) – VAF 183
Location: Ireland (Hybrid, Remote Work Possible)
Department: Quality & Compliance
Contract Type: Permanent
About ProductLife Group:
ProductLife Group (PLG) is a rapidly growing consultancy dedicated to improving human health by delivering regulatory compliance services. PLG holds its own MIA, ManA, and controlled drug licences in the UK and Ireland, enabling the importation of medicines into the EEA and the UK. The company also develops, implements, and assists in the operation of WDA’s for its clients. The role of the Responsible Person (RP) is critical to maintaining regulatory compliance across these operations.
Role Overview:
PLG is seeking a Quality Associate / RP with a proven track record and a drive for continuous development. The successful candidate will play a key role in maintaining and improving quality management systems (QMS) and ensuring compliance with Good Distribution Practice (GDP) requirements.
Key Responsibilities:
As Responsible Person (RP):
Act as and be named as a Responsible Person (RP) on the licence.
Ensure the Quality Management System (QMS) is implemented, maintained, and continuously improved.
Host and respond to regulatory and client audits.
Ensure all activities comply with regulatory requirements and the terms of the licence.
Assess the impact of deviations on stored products.
Conduct and ensure self-inspections are performed, and subcontracted activities are adequately assessed.
Support and provide input to the Regulatory Affairs team when required.
As Quality Associate:
Support the Quality Assurance Manager in ensuring the effective operation of the QMS.
Ensure timely and accurate collection and recording of information within the QMS for KPI monitoring.
Provide technical and quality system support to the wider business.
Collaborate with the internal Quality team and clients to improve systems and maintain compliance with GMP/GDP and regulatory requirements.
Key Duties and Responsibilities:
Ensure systems are in place for safe and secure transportation, storage, and distribution of products.
Ensure storage facilities meet regulatory standards for security, segregation, cross-contamination prevention, and temperature control.
Develop and maintain written procedures for all GDP activities.
Conduct relevant audits to ensure ongoing compliance using risk assessment tools.
Prepare and maintain technical agreements aligned with regulatory requirements.
Role Requirements:
Minimum of 3 years’ experience in the pharmaceutical wholesale distribution sector working with a WDA QMS.
Currently named as an RP on a licence with the HPRA. Consideration will be given to current Deputy RPs with at least 6-12 months’ experience.
Knowledge of a range of dosage forms.
Thorough understanding of current GDP requirements.
Audit experience in GDP distribution facilities.
Behavioral Competencies:
Customer Focus: Strong verbal and written communication skills, with the ability to understand and meet customer requirements.
Teamwork: Ability to work effectively in a multidisciplinary team and across departments.
Quality and Safety: Commitment to maintaining quality standards and supporting continuous improvement.
Flexibility: Ability to adapt to changing business needs and priorities.
Gujarat :
Ahmedabad | Ankleshwar | Baroda | Bharuch | Gandhinagar | Gujarat | Halol | Jhagadia | Mehsana | surat | Tarasadi | Vadodara | Vapi |Maharashtra :
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Siliguri |Illinois :
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Queensland |Melbourne :
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Canada |Quebec :
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Brussels |Antwerp :
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Brazil | Sao paulo |Attica :
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Greece |North Island :
Auckland |New Zealand :
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Vienna |Catalonia :
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Madrid |Cebu Province :
Cebu City |Philippines :
Manila |Croatia :
Croatia |Zagreb :
Zagreb |Estonia :
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Ho Chi Minh City |Italy :
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Japan | Saitama |Tokyo :
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