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Quality Compliance Pharmacist
4 weeks ago
Overview The Quality Compliance Pharmacist is responsible for ensuring compliance with Good Distribution Practice (GDP) and regulatory requirements across pharmaceutical and medical device operations. This includes support of quality systems, product release, validation, and supplier management. The role involves maintaining regulatory licenses, managing pharmacovigilance and vigilance activities, handling audits and CAPAs, and ensuring up-to-date documentation and training programs. The officer also supports compliance with MDR/IVDR, oversees change control processes, and ensures products meet quality standards before distribution, working cross-functionally with internal teams and external partners. The role will also support regulatory, medical information and pharmacovigilance requirements as applicable.
Principal Duties and Responsibilities
Quality Management & Compliance
Oversee Good Distribution Practice (GDP) activities for pharmaceutical and medical device products.
Ensure temperature control and environmental monitoring of storage and distribution areas.
Manage quality operations, including deviation/NC handling, root cause analysis, and implementation of corrective and preventive actions (CAPAs).
Perform risk assessments for distributed products and processes in line with regulatory and company standards.
Maintain and control documentation, including SOPs, records, and batch release documents.
Lead and participate in internal and external audits, including preparation, execution, and follow-up on findings.
Regulatory
Prepare, submit, and maintain facility licenses, registrations, and renewals with national and international regulatory bodies.
Oversee compliance with Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR) requirements.
Monitor regulatory updates and assess business impact (regulatory intelligence).
Review and approve product labelling, promotional materials, and advertising to ensure regulatory compliance.
Vigilance & Safety
Manage pharmacovigilance and medical device vigilance activities, including adverse event reporting and follow-up.
Handle product complaints and coordinate recalls in line with regulatory expectations and internal procedures.
Validation & System Control
Oversee validation of systems, equipment, and processes involved in distribution.
Ensure compliance with data integrity.
Training & Development
Develop, maintain, and deliver training programs to ensure all staff comply with GDP, GMP, and quality policies.
Ensure training records are complete and up-to-date.
Supplier & Warehouse Oversight
Qualify and manage suppliers and third-party service providers, including audits and performance monitoring.
Support warehousing operations to ensure GDP compliance, including good housekeeping, pest control, and material handling.
Product Release
Ensure that pharmaceutical and medical device products meet quality and regulatory standards prior to release for distribution.
Change Control
Manage the change control process for systems, products, and procedures, assessing potential risks and regulatory impacts.
Requirements
Qualified Pharmacist
Auditor Certified (e.g. ISO 9001 and/or ISO 13485 or pharma equivalent)
Responsible Person eligibility
1-3 years experience of GDP/GMP/ MDR, IVDR and ISO systems
Validation experience including computer system validation
Flexibility to travel and ability to audit effectively
Desirable Skills And Experience
Strong knowledge of GDP, GMP, MDR, IVDR, and local regulatory frameworks.
Experience in managing audits, CAPA, and complaint investigations.
Familiarity with validation protocols and quality risk management tools.
Excellent communication, organizational, and documentation skills.
Ability to work cross-functionally and liaise with regulatory bodies, suppliers, and internal teams.
Pro-active
Flexible and adaptable to changing environment
Ability to interface effectively with all levels within the company as well as organizations outside Fannin (regulatory agencies)
Proven problem solving and trouble shooting skills
Strong oral and written communication skills
Strong interpersonal and leadership skills
Role
The role demands a well-organised approach, underpinned by the ability to communicate effectively with people at all levels, both verbally and in writing. Reliability, IT literacy and the ability to plan and complete projects to set timelines are essential.
Other Information
Full-time, permanent role
Available to work beyond normal office hours, including travel as required.
Although the above is a description of the requirements of the role, as stated in your contract of employment, you may be required to carry out other reasonable duties as the Company may require from time to time.
DCC Vital operates quality and EHS management systems across all sites and staff agree to comply within the requirements relevant to their role.
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