QA Specialist

Summary:

Responsibilities

* 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.

* Carries out tasks related to the administration of site supplier approval process.

Requirements

* 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.

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