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Orion Group are looking for a QA Specialist for our multinational pharmaceutical client based in the Cork area on an initial 24-month contract with the potential to extend.
Provides support and direction to all departments in respect of specific quality system elements to ensure business, quality and compliance goals are met following client standards. Partner with other Departments to ensure that compliance systems are implemented in an efficient manner.
This position is responsible for carrying out tasks and projects related to management of Quality Assurance activities at the company as required by Good Manufacturing Practice (GMP). These activities include Batch release, Change control, Event management and Annual product review activities. Provides support and direction to all departments in respect of specific quality system elements to ensure business, quality and compliance goals are met.
Main Responsibilities of the role
- 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
- Approves and compiles where appropriate validation protocols and reports (analytical, cleaning, computer, process, equipment, etc.)
- 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
- Perform GMP audits on-site and vendor facilities as required
Desired Experience and Background of the successful candidate
- Bachelor's 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
- Experience in auditing of external suppliers, contractors and vendors
- 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
Our role in supporting diversity and inclusion
As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.
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