Telephone: 086 8168298
QA Specialist - Normal
Our client, a pharmaceutical company in Cork are currently looking to recruit a QA Specialist - Normal for their site.
General Scope of 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 Standard of Leadership behaviour model.
- Partners with other Departments to ensure that compliance systems are implemented in an efficient manner.
- 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.
Key Skills and Competencies required:
- Excellent interpersonal skills
- Ability to operate as part of a team is critical.
- Customer focus
- Excellent communication skills both written and verbal
- Attention to detail
- Good problem solving skills
- Results and performance driven
- Adaptable and flexible
- Decision making
Other Skills, Experience and Education
- 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 QA Specialist - Normal role in Cork please contact Niamh Hlubek 086 8168298 / firstname.lastname@example.org
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