QA Specialist

2 weeks ago

Cork, Ireland Cpl Healthcare Full time

QA Specialist Senior

On behalf of our Client, Kenny-Whelan are hiring QA Specialist Senior for the Cork area for one of its Global Life Science companies in Cork.

Responsibilities

- Batch Record Review and material release to ensure compliance with GMP requirements.

- Quality review and approval of Master Batch Record (MBR) record for routine cleaning and process activities, including Automation recipe updates.

- QA Review and Approval of SOPs, Work Instructions and forms from other departments.

- Attendance at Daily/Weekly Operations led Team Meetings.

- Responsible for Walkdowns & Inspection Readiness Walkdowns from a QA perspective.

- QA review and approval of Warehouse Shipping Picklist.

- Primary QA point of contact for Quarantine Shipments.

- Responsible for Batch Book Filing & Archival.

- QA review and approval of quality non-conformance (NC) records and customer complaint non-conformance records.

- Initiation and ownership of QA non-conformance records.

- Responsible for periodic review of Quality Assurance and Quality Systems SOPs.

- Primary Quality point of contact for attendance at Root Cause Analysis meetings.

- Primary QA point of contact for the Returns process.

Qualifications/ Experience

- Third level Degree in a Science or Pharmaceutical Discipline

- A minimum of 3 years of experience within the Pharmaceutical Industry (sterile or aseptic environment)

- A working knowledge of quality processes and systems

- Demonstrated knowledge and application of industry regulations including those of FDA, HPRA, EMEA and other authorities.

Skills/ Competencies required

- Build strong productive relationships.

- Demonstrates ability to work with teams and individuals.

- Seeks opportunities to grow and develop professionally.

- Uses best practices to improve business operations.

- Holds self-accountable for compliant and flawless execution.

- Takes personal responsibility for decisions that successfully build customer value

- Effectively manages and adapts to change

- Always demonstrate Integrity

- Ability to work independently, manage own time and meet deadlines as appropriate

All applications will be treated with the strictest confidence

Please note that as this is a Contract role you need to be eligible to work in Ireland, hold a Stamp 1G or Stamp 4 Visa

Kenny-Whelan Contact

For further information please contact Carmel Synnott on 00 353 21 4665405 / 087 7422268 or sendyour updated CV to csynnott@kenny-whelan.ie

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