Engineering & Electronics
The QA Specialist will be responsible for the following.
Managing compliance activities and QA operational activities related to operational projects 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.
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
As a QA Specialist, your typical day may include:
- Supports the development and management of GMP compliance systems.
- Carries out tasks related to the administration of site nonconformance management system and change control system.
- Partners with Engineering, Technical Operations & Maintenance 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, 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.
- Bachelors 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.
- Familiarity with PAT Management software (e.g SynTQ)
- Statistical skills and experience with process analytic technology (e.g Raman)
- Familiarity with Data Visualisation software (e.g Tableau)
Interested candidates should submit an updated CV.
Please click the link below to apply, call Holly on 0214297900 or alternatively send an up-to-date CV to firstname.lastname@example.org
***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in Ireland***