Our Client a pharmaceutical company in Cork is looking to hire two Quality Assurance Specialist for their site on a contractual basis.
Managing compliance activities and QA operational activities related to operational project as required by Good Manufacturing Practice (GMP). These activities include, C&Q and Validation activities, Data Integrity and CSV support, change control, non-conformance investigations, compliance auditing, and other related quality system elements.
As a QA Specialist, your typical day may include:
- Supports GMP activities from operational through to Laboratory support programs.
- Partners with other Departments to ensure that compliance programs are completed in an efficient manner and are effectively maintained.
- Responsible for implementation of systems and procedures for the management of change control and deviation management, as it applies to plant installations, systems, and operations in accordance with GMP.
- Quality oversight of project activities including but not limited to, C&Q activities and process validation through to commercial manufacture.
- Participates as a key quality member in inspections and audits of JSCI by external parties/agencies.
- Key participant within the QA team in the execution of their duties.
- Executes the activities of the group within quality to create a synergistic approach to goals and tasks.
- Domestic and international travel may be required.
- Bachelor’s Degree in a scientific/technical discipline required
- A minimum of 5 years’ experience in a quality 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 including those of FDA, HPRA, EMEA and other authorities.
- Focus on patients and customers at all times.
- Advanced degree (MS, MBA, PhD) preferred
- Experience in C&Q, and Process validation
- Experience in direct interactions with regulatory agencies during site inspections.
You will have fulfilled the educational requirements for this role and have experience in a similar role within a FDA/EMEA regulated environment.
What you’re great at:
- 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
- Integrity, trustworthiness and objectivity
- Knowledgeable of FDA/EMEA regulatory requirements
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