QA Specialist

Recruitment Consultant

Adam Chapman

Contact Details

[email protected] +44 (0) 330 335 9438

Posted

4 days ago

This position is responsible for carrying out tasks and projects related to management of Quality Assurance activities as required by Good Manufacturing Practice (GMP). These activities include Incoming material release, Batch release, Change control, Event management, Supplier qualification, Annual product review and Validation compliance activities.

Duties

Batch Record Review & material release to ensure compliance with GMP requirements.
Carries out tasks related to the administration of event management systems including Review & Approval of Event, Deviations, and Customer complaints.
Carries out tasks related to the management of batch records design and approval.
Carries out administration of the SAP Quality Management Module.
Carries out tasks relating to the management of site change control systems.
Compiles Annual Product Reviews.
Supports all validation activities on site as described in the Site Validation Master Plan.
Approves and compiles where appropriate validation protocols and reports (analytical, cleaning, computer, process, equipment, etc.).
Supports system qualification and process validation activities.
Reviews and approves SOPs/work instructions/forms from other departments on behalf of Quality Assurance
Co-ordinates and assists in the preparation for regulatory and customer GMP inspections of the site.
Participates in the introduction of new process or modified process steps, as part of a New Product Introduction Team (NPI)
Perform GMP audits on-site and vendor facilities as required.
Performs on the floor walkdowns regularly to ensure process and facilities are maintained to GMP standards.
Carries out tasks related to the administration of site supplier approval process.

Key Skills & Competencies Required

Excellent interpersonal skills
Ability to operate as part of a team is critical.
Customer focus
Innovative
Excellent communication skills both written and verbal
Attention to detail
Good problem solving skills
Results and performance driven
Adaptable and flexible
Decision making

Qualifications & Experience

Essential

Bachelors Degree in a scientific/technical discipline required
A minimum of 3-5 years’ experience in a quality, validation or compliance role within the biological and/or pharmaceutical industry.
Knowledgeable of FDA/EMEA regulatory requirements applicable to biologics and/or pharmaceuticals. Ability to apply GMP regulations and other FDA and international guidelines to all aspects of the position.
Demonstrated knowledge and application of industry regulations as they apply to quality, including those of FDA, IMB, EMEA and other authorities.

Desirable

Experience in auditing of external suppliers, contractors and vendors.

Industry

Life Sciences

Contract Type

Contract

Location

Ireland

Work Model

On-Site

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