Our client, a medical device company in Cork are currently looking to recruit a QA Specialist for their site on a contract basis.
Position Description and Responsibilities
- This position is responsible for carrying out tasks and projects related to managing compliance activities during qualification and validation related to the company's projects as required by Good Manufacturing Practice (GMP).
- These activities include review and approval of change controls, non-conformance investigations, and protocols. Primary Tasks and Responsibilities
- Provides support and direction to all departments in respect of specific quality system elements to ensure business, quality and compliance goals are met following the company's Standard of Leadership behaviour model.
- Partners with other Departments to ensure that compliance systems are implemented in an efficient manner.
Supports the management of GMP compliance systems through the following activities:
- Assesses compliance systems on ongoing basis to identify opportunities for process improvement.
- Carries out tasks related to the administration of project and site non-conformance management systems.
- Reviews and/or approves non-conformance investigations and their associated documentation.
- Manages entry of non-conformance records into the appropriate electronic system.
- Tracks investigations from the initiation through closure processes and advises relevant personnel on the status of investigations and associated CAPA and commitments, as appropriate.
- Coordinates investigation activities to ensure root causes are identified and that corrective actions are appropriate.
- Approves closure of non-conformance investigations on completion of the investigation and associated corrective actions.
- Carries out tasks related to the management of project and site change control systems:
- Reviews and/or approves change control requests, implementation actions, and request closures.
- Manages entry of change control records into the appropriate electronic system.
- Tracks records from the initiation through closure processes and advises relevant
Non-Technical Skills and Additional Details
- Influence and facilitate the work of other departments and functions in achieving and maintaining state of GMP compliance.
- Establish effective partnerships with other individuals, departments and GBSC affiliates so that compliance activities are well understood and coordinated.
- Actively promote improvement programmes towards continuous compliance during qualification and validation.
- Actively promote and apply strategic thinking to compliance activities
- Facilitates the work of other departments and functions in achieving and maintaining state of GMP compliance during qualification and validation activities.
- Establishes effective partnerships with other individuals and departments so that quality systems and compliance activities are well understood and executed to a high standard.
- Interface with all site departments, Operations and Maintenance.
- Contact with Quality Assurance Manager for management of qualification and compliance activity.
- Directors and managers of other departments for coordination of qualification document reviews and approvals, including associated change controls, non-conformance investigation, and completion of commitments.
Qualifications and Experience
- Bachelor's Degree in a scientific/technical discipline required
- A minimum of 2 years' experience in a quality, validation or compliance role within the biological and/or pharmaceutical industry.
- Demonstrated knowledge and application of industry regulations as they apply to qualification and validation, including those of FDA, IMB, EMEA and other authorities.
- 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.
- Experience in statistical sampling plan development.
- Experience in a biopharmaceutical or pharmaceutical plant start-up.
For further information on this role in Cork please contact Bimi Felix on 091730022 /firstname.lastname@example.org
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