QA Specialists

Prochem Engineering; Waterford; On-site; EUR 40,000 - 62,000; Full time

Job summary

Genzyme, Waterford pharmaceutical QA team, requires a QA Specialist to ensure products are manufactured, stored and packaged in line with cGMP and to participate in audits and documentation review.

You will develop and deliver GMP training, review procedures and drive continuous improvement in the quality system on site in Waterford.

Qualifications

• Minimum 2 years’ experience in a similar QA role.
• Experience in a GMP environment is required.
• Strong knowledge of cGMP in regulated environments.
• Excellent accuracy and attention to detail.
• Good interpersonal and presentation skills.
• Proficient with computer packages.

Responsibilities

• Ensure products are manufactured, stored and packaged in compliance with cGMP.
• Develop GMP training packages and deliver training.
• Prepare and review procedures and batch documentation.
• Perform audits of all departments to schedule.
• Maintain quality system and ensure compliance with cGMP.
• Support continuous improvement initiatives.

Skills

Quality Assurance

GMP knowledge

cGMP knowledge

Attention to detail

Interpersonal skills

Presentation skills

Computer skills

Education

Science degree

Tools

GMP systems

Job description

QA Specialists required for a pharmaceutical client based in Waterford

Job Purpose:

• Working as part of the Quality Assurance team on site ensuring products are manufactured, stored and packaged in accordance with cGMP
• Support the development of GMP training packages and delivery of training
• Participate in the preparation and review of procedures and batch documentation
• Perform audits of all departments to agreed schedule
• Ensure the quality system at Genzyme is effectively implemented and maintained
• Ensure practices meet cGMP requirements

Job Requirements

• Acts as Quality Point person for systems / processes providing guidance / feedback on quality issues
• Perform timely review of documentation / investigations /reports highlighting and assisting in the resolution of concerns commensurate with the risk
• Work with relevant departments to ensure timely closure of quality actions / findings
• Actively contribute to continuous improvement initiatives.
• Conduct duties in a safe manner and report all safety issues or concerns
• Maintain work area to good housekeeping standards
• Ensure attendance at place of work when required
• Support team in achieving team goals/targets
• Attend team meetings as required
• Actively contribute to continuous improvement initiatives
• Measure and report RFT / trend data and work with departments to resolve recurring issues
• Participate in internal supplier and regulatory audits and key quality initiatives as appropriate
• Perform critical/ constructive review of procedures and practices
• Support investigation of deviations ensuring all product deviations are closed prior to product release
• Ensure compliance to cGMP at all times

Qualifications and Experience

• Third Level qualification (degree in science or related discipline preferred).
• Minimum of 2 years’ experience in a similar role
• Experience working in a GMP environment is required
• Very good knowledge of cGMP in a regulated environment
• Excellent accuracy and attention to detail
• Excellent interpersonal skills
• Good presentation skills
• Working knowledge of computer packages
• Flexible approach - comfortable with on-going change