Job Title: QA Compliance Specialist
This is a 12-month contract role, working Monday to Friday, 8am-4:30pm, onsite at our Client site in Sligo.
Primary Function
To ensure that all products leaving the site meet the required standards for marketed and investigational drug products.
Key Responsibilities
* Leading/assisting in investigations of product or manufacturing process non-compliance
* Reviewing and auditing completed Batch Records
* Reviewing Manufacturing Logs as required
* Completing quality reviews of operations documentation (SOPs, JSTMs, Risk Assessments)
* Completing Incoming Raw Material checks, including product status maintenance
* Providing Stability Program Support, e.g. sample pulls, weekly checks, protocol generation
* Administering Quality Logs, e.g. QA Hold, Sample Request
* Leading daily walk-around inspections of manufacturing areas
* Driving continuous improvements and simplifying site processes and procedures to ensure compliance
Requirements
* Third-level degree in a science, quality or engineering discipline
* A minimum of three years' experience in a quality/operations role in a highly regulated GMP environment
* Experience in biologics manufacturing is highly desirable
* Experience in aseptic processing gained within either a quality or operations role is highly desirable
* A strong knowledge of regulatory requirements is required
* A high level of attention to detail and mental concentration to ensure accuracy and total compliance with procedures
* Proven problem-solving skills and ability to adapt to new requirements
* Innovative thinking, proposing, demonstrating and implementing new solutions
* Results-driven, striving to meet targets and metric standards
* Decision-making within quality systems, adhering to regulatory and international standards
About PE Global
We are a recruitment agency and we will do our utmost to provide feedback on your application. We may discuss other suitable positions with you, unless you opt out. Your CV will be shared with relevant personnel and Team Leaders.
Skills
Compliance, Operations, Quality Assurance