Our client, a medical device company in Cork are currently looking to recruit a QA Specialist for their site.
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 Material release, Change control, Event management, supplier qualification, Annual product review and validation compliance activities.
Provides support and direction to all departments in respect of specific quality system elements to ensure business, quality and compliance goals are met.
- 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. Ensures that Batch Operating Instructions are compliant with filed descriptions.
- Carries out administration on SAP MRP.
- Carries out tasks relating to the management of site change control systems.
- Supports & GMP conducts GMP/ICH Q7a training as required.
- 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.
- Adheres to and supports the company safety policy and safety programmers.
- Engages in Site Credo initiatives
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
- Contribute to innovative and viable products, services and/or solutions, adding value. Challenges the status quo and adapt to change, taking advantage of opportunities to have a positive impact.
- Identifies and communicates meaningful risks, takes appropriate action and demonstrates an awareness of the highest standards of quality and compliance.
- Take accountability for their performance and development alongside supporting talent acquisition and the development of others.
- Leverages diverse perspectives, backgrounds and talent to generate effective ideas or solutions and engage in transparent and constructive conversations, contributing to high-performance teams.
Third level scientific degree and at least 5 years QA/Validation experience.
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
For further information on this QA Specialist role in Cork please contact Jenny Dore on 0212066287 / firstname.lastname@example.org
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