QA Officer

Responsibilities

• Support the Qualified Person (QP) in the execution of legal and operational duties regarding the certification and release of medicinal products.
• Administer and control core systems within the Pharmaceutical Quality System, including internal audits, vendor management, deviations, complaints, CAPA, and change control.
• Perform pre-certification assessments of batch records and generate draft QP certificates.
• Coordinate and perform investigations into internal and external quality issues.
• Author standard operating procedures and provide QA and GMP-related training.
• Support and host client audits of the facility.
• Review and approve offsite shelf life extension labelling activities and validation/qualification protocols.

Requirements

• Minimum of two years of experience in a Quality role within a regulated industry (pharmaceutical, clinical, biotechnology, or medical device).
• Qualification in a life sciences subject (HNC, HND, or degree) or equivalent technical experience within the pharmaceutical industry.
• Strong knowledge of Good Manufacturing Practice (GMP) and EU legislation and guidelines.
• Familiarity with standard computer applications.
• Strong communication and interpersonal skills, with the ability to maintain relationships at all levels.
• High level of self-motivation and the ability to make rational, informed decisions regarding quality incidents.

About the Company

PCI Pharma Services is a global provider of pharmaceutical services, acting as a bridge between life-changing therapies and the patients who need them. We focus on providing quality and operational excellence through a culture of purposeful work and intentional learning.