QA Compliance Specialist

Desired Skills: compliance,operations,quality assurance

PE Global is currently recruiting for QA Compliance Specialist for a Client site in Sligo:

This will be a 12-month initial contract role – days role 8-4.30 Monday to Friday – onsite

Other duties as assigned.

Primary Function:

Ensure that all products leaving site meet the standards required for marketed and investigational drug products.
Ensure that products and aseptic process simulations manufactured at site meet the requirements of the end users, regulatory authorities and of the company.
Providing quality and compliance oversight and assistance to the Operations function of the company to manufacture products in compliance with all site policies and procedures.

Key Responsibilities:

Leading / Assisting in investigations arising out of product or manufacturing processes non-compliance.
Review/Audit of completed Batch Records.
Review of Manufacturing Logs as required.
Completion of quality review of operations documentation (SOPs, JSTMs, Risk Assessments)
Completion of Incoming Raw Material checks, including product status maintenance (as required).
Provide Stability Program Support, e.g. sample pulls, weekly checks, protocol generation (as required).
Administration of Quality Logs, e.g. QA Hold, Sample Request.
Lead operations floor daily walk around of manufacturing areas.
Drive continuous improvements and simplify site processes and procedure, specifically relating to the Operations function to ensure compliance is maintained at all times.
Other support as deemed necessary

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.
Requires a high level of attention to detail and mental concentration, to ensure accuracy and total compliance with procedures at all times.
Requires proven problem-solving skills and the ability to adapt to new requirements.
Requires innovative thinking, where new and untested solutions are proposed, demonstrated and implemented on a regular basis.
Must be results driven striving to meet all targets and metric standards as set by site/department and division leaders.
Decision making within confines of quality systems in relation to applicable regulatory and international standards.
Expected to handle all day to day quality issues/queries from the operations function, however, if a major problem occurs they will confer with relevant personnel or Team Leader.

Interested candidates should submit an updated CV, marked for the attention of Audrey