Senior Quality Specialist – Biotech

Job title:

Senior Quality Specialist – Biotech

Company

Morgan McKinley

Job description

This is a great opportunity for a senior quality specialist to join a highly regarded biotech facility in Cork in a key role within the operational / manufacturing support teamMain Purpose and Objectives of Position:

• Perform ongoing monitoring that includes – monitoring of quality systems, production area time on floor audits, verification of the effective implementation of key GMP programs and review of systems that impact product quality to ensure that they operate in a state of control.
• Provide QA ownership and leadership for products manufactured in area of responsibility.
• Manage quality-related matters specific to area of responsibility.
• Responsible for approving appropriate quality-related documents.
• Carry out day-to-day activities in compliance with site safety policies and procedures.
• Promote and encourage safe practices & promptly report any safety concerns.
• Provide coaching and mentoring to operations personnel and to other QA reps on appropriate risk management to provide appropriate and timely solutions to compliance in a business focused fashion

Key Responsibilities:

• Review and approval of other key GMP documents such as GMP standard operating procedures, raw material specifications, sampling protocols, master formulas, process flow documents
• Review and approval of GMP documents associated with qualification and validation including IQ/OQ/PQ & validation documents for facility, equipment, computer systems, GMP utilities, analytical methods, and processes, stability data, sampling protocols and Annual Product Reviews.
• Re-identification, re-evaluation & disposition of raw materials, intermediates and packaging components used in the manufacture of relevant pharmaceutical products where necessary.
• Evaluation and contribution of regulatory information to regulatory documents Monitoring of GMP compliance, GMP programs including data integrity and systems by ensuring a regular presence the area of responsibility
• Participation in the Site Self-Inspection program and audit of production, systems and service areas for compliance with Product Quality Systems, policies, guidelines and procedures.
• Reports and escalates critical quality issues to the appropriate level of quality management for final resolution.

Key requirements & skillset:

• Hons BSc, MSc, or PhD in Pharmacy, Chemistry, Engineering, Quality, or related discipline, with a minimum of 3 years relevant experience in QA
• Experience working in cross functional teams and proven ability in decision making
• Demonstrates ability in critical thinking, data analysis, problem solving and experience in root cause analysis.
• Strong organisational skills, including ability to follow assignments through to completion.
• Understanding of Data Integrity and its applications
• Self-motivated, positive and ability to work under pressure.
• Experience supporting on internal, external and regulatory audits
• Demonstrates flexibility and adaptability to meet business needs.

This is a days role but if you have a preference for shift positions this can be discussed further at the early stages of the interview process. Once trained up there is an option for hybrid working.If you would like to find out more about this role please click the ‘Apply Now’ button below or reach out to Kellie on 021 2300 300.Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.BY APPLYING FOR THIS ROLE YOU ARE AGREEING TO OUR WHICH TOGETHER WITH OUR GOVERN YOUR USE OF MORGAN MCKINLEY SERVICES.

Expected salary

Location

Cork

Job date

Tue, 06 Aug 2024 23:33:56 GMT

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