QA Specialists 4 cycle shift

Wallace Myers International; Munster; On-site; EUR 48,000 - 83,000; Full time

Benefits offered by this job

Shift premium

Subsidized gym

Double pay on bank holidays

8-hour bonus after bank holidays

Job summary

Wallace Myers International in Waterford is hiring QA Specialists to join a Pharma/GMP operations team on a contract basis. The role requires 2+ years in QA within a GMP environment and experience with sterile biopharma operations preferred.

You will work on a 24/7 shift rotation (two 12-hour day shifts, two 12-hour night shifts, then four days off) with weekend/bank holiday coverage. Bank holidays attract double pay; an 8-hour bonus is paid after every bank holiday.

Qualifications

• 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.
• Working knowledge of computer packages.
• Flexible approach – comfortable with ongoing change.

Responsibilities

• 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.

Skills

Interpersonal skills

Attention to detail

Accuracy

Computer skills

Flexible / adaptable

Education

Bachelor's degree in science or related discipline

Job description

€35.00 - €60.00 per hour Shift premium, Subsidized gym and

Jenn at Wallace Myers is hiring QA specialists to work on contract at our client's site in Waterford

QA Specialists 4 cycle shift

Must have Pharma QA operations experience-general QA won't suffice.

Sterile Biopharma operations experience preferred

This team operates on a 24hour, 7day schedule.

• Two 12 hour day shifts (07:00 to 19:00)
• Followed by two 12hour night shifts (19:00 to 07:00)
• Followed by four consecutive days off

Workers must be available to cover weekends and bank holidays. Bank holiday shifts are paid at double rate.

Additionally, each person on the 24/7 rotation receives an 8hour bonus (up to 80 hours per year) after every bank holiday, regardless of whether they worked that day.

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

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
• 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

Please note: Due to the project nature - These are professional service (Ltd) contract positions requiring immediate EU work authorization (EU Passport or Stamp 4). We are unable to consider candidates requiring visa sponsorship or those on Stamp 1G graduate visas for these contract roles.

All applications will be treated with the strictest of confidence.

Privacy Policy:

By applying for this role you are agreeing that your details will be stored in our database and may be considered for similar future positions. For more info see wallacemyers.ie/privacy-policy