Quality , Science, Pharmaceutical & Food
QA Specialist – East Cork
- Cork City
PE Global is currently recruiting for a QA Specialist for a client site in East Cork –
12 month initial contract
QA Specialist supporting Operations (12 months)
This is a contract role and this position requires experience and expertise in the quality support of multiple Operation and project activities. The role includes review and approval of manufacturing operations documentation and validation documentation from a quality perspective. The successful candidate will be required to work on complex issues where analysis may require an in-depth assessment, considering many variables and potential consequences. This position requires a sound knowledge of quality assurance systems, principles, industry practices and standards. The candidate will be required to exercise judgment, within well-defined and established procedures and practices, to identify problems and appropriate actions and to generate alternatives and recommendations within defined processes. The candidate must be proactive in their daily activities and interactions.
- Participations within inter-departmental and cross-functional teams.
- Performs a wide variety of activities to ensure compliance with applicable regulatory requirements through quality support operations.
- Performs QA review and approval on documents that are routine in nature, where ability to recognize deviation from accepted practice is required.
- Supports development of solutions to more complex problems, identifies deviations from accepted practice and evaluates impact assessment as required.
- Involvement in investigations and corrective and preventive action (CAPA) recommendations.
- May assist in review and evaluation of proposed changes, qualification and validation documentation as related to operations.
- Performs walkthroughs on behalf of the QA department to ensure site compliance to GMP.
- Maintains programs and processes to ensure high quality products and compliance with current Good Manufacturing Practices (GMPs).
- Participates in QA review and approval of artwork and product master data.
- May work with secondary packaging contract organisation and perform QA review and approval of associated documents.
- Participates in authoring, reviewing and approving Standard Operating Procedures (SOPs)/other types of controlled documents.
- Normally receives very little instruction on routine work, general instructions on new assignments.
Knowledge and Skills:
- Prior experience in pharmaceutical industry is preferred (ideally within this QA role).
- Working knowledge of current Good Manufacturing Practices (cGMPs) (FDA / EMEA standards and quality systems)
- Demonstrates proficiency in application of QA principles, concepts, industry practices and standards with specific emphasis on validation and packaging requirements.
- Previous experience with change management and validation documentation is advantageous.
- Basic knowledge of OPEX Lean tools, and root cause analysis tools used for identifying and correcting deviations.
- Demonstrates audit and investigation skills, and report writing skills.
- Demonstrates strong verbal, technical writing and interpersonal skills.
- Proficiency in Microsoft Office applications.
Typical Education & Experience:
- 4+ years of relevant experience in a GMP environment related field and a BS or BA.
- 2+ years of relevant experience and a MS.
- Prior experience in pharmaceutical industry is preferred.
Interested candidates should send their CV to Audrey.firstname.lastname@example.org or call 0214297900