QA Specialist

Adecco; Waterford; On-site; EUR 42,000 - 64,000; Full time

Job summary

Genzyme is seeking a Quality Assurance professional to join our on-site team, ensuring products are manufactured, stored and packaged in accordance with cGMP standards and internal quality procedures.

The role involves developing GMP training packages, delivering training, preparing and reviewing procedures and batch records, and conducting audits across all departments to uphold the quality system and drive continuous improvement.

Qualifications

• Degree in science or related discipline (third level).
• Minimum 2 years' experience in a similar role.
• Experience 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.

Responsibilities

• Work 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 is effectively implemented and maintained.
• Ensure practices meet cGMP requirements.
• Actively contribute to continuous improvement initiatives.
• Participate in internal supplier and regulatory audits and key quality initiatives.

Skills

Attention to detail

Interpersonal skills

Presentation skills

Flexibility

Teamwork

Self-starter

Computer skills

Education

Degree in science or related discipline

Tools

Computer packages

Job description

Duties:

• You will be 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 practises 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 & 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

Personal Characteristics:

• Takes personable responsibility for their actions
• Excellent attention to detail.
• Good communicator who is comfortable to work as part of a team
• Focused on achieving results
• Self-starter and able to work under minimum supervision

Desired Skills and Experience

Sterile manufacturing, GMP, Science Degree, Pharmaceutical, cGMP, Quality, Quality Assurance, Engineering