At a Glance
- Tasks: Ensure cleanroom compliance and support training in aseptic techniques.
- Company: Leading company in the pharmaceutical sector with a focus on quality.
- Benefits: Generous leave, healthcare plan, pension scheme, and employee perks.
- Other info: Opportunities for career growth and professional development in a supportive workplace.
- Why this job: Join a dynamic team ensuring product safety and quality in a high-tech environment.
- Qualifications: Degree in biological science or engineering, or 2 years' cleanroom experience.
The predicted salary is between 30000 - 40000 € per year.
Job ref: QACM
Job type: Permanent
Location: Newry
Closing date: Thursday 14 May
Job Overview
QA Compliance Microbiologist required within our QA Cleanroom Compliance department. You will provide quality oversight to ensure adherence to all aspects of cleanroom behaviours, gowning, aseptic technique, cleaning & disinfection, transfer procedures and facility standards for classified cleanrooms in line with regulatory requirements. You will also support with training, evaluation and continuous improvement projects within our aseptic cleanrooms.
Main Activities/Tasks
- Ensure alignment with best aseptic practices, standard operating procedures and GMP requirements.
- Participating in cleanroom inspections, promoting continuous improvement and compliance.
- Identifying and documenting all deficiencies found during inspections and support with assessing risk to product.
- Initiating and supporting remediation measures and investigations in response to inspections finding and environmental monitoring trends.
- Arrange & deliver initial training for personnel working in the classified cleanroom environment.
- Arrange & deliver periodic re-training in line with SOP & regulatory requirements and/or in response to environmental monitoring trends.
- Assisting in reviewing and compilation of Standard Operation Procedures and other technical documentation in line with current GMP and regulatory requirements.
- Support with selection and validation of new cleanroom cleaning, disinfectant, cleanroom consumable products e.g., mops, wipes, garments, stationary.
- Provide technical support for new and upgraded classified cleanroom facilities and cleanroom equipment.
- Support simplification & efficiency initiatives.
- Participate in customer and regulatory audits.
Essential Criteria:
- Educated to at least Degree level or equivalent in a biological science or engineering field or have minimum 2 years' experience within a high-grade cleanroom environment.
- Excellent attention to detail and highly organised.
- Strong computer skills and proficient in the use of Microsoft Office with the ability to generate reports.
- Flexibility to work a shift pattern which may incorporate nights and/or weekends.
- Excellent oral and written communication skills.
Desirable Criteria:
- Practical experience of good aseptic technique in a manufacturing cleanroom.
- A minimum of 1 years' experience in a training role.
- Prior experience of troubleshooting, performing investigations and preparing for regulatory inspections / customer audits.
- Good knowledge of cleanroom design; current good manufacturing practice; environmental monitoring requirements for aseptic processing facilities.
- Prior auditing experience.
Duration: Full Time, Permanent
This role will involve working a 3 shift pattern: Monday to Friday 6am-2pm, Monday to Friday 2pm-10pm, Sunday night to Friday morning 10pm-6am. The first 8-12 weeks training will be Monday to Friday 9am-5pm.
Location: Newry
Additional Information:
This role will be based in a site that produces and handles penicillin, and as such, this role would not be suitable for those that have a penicillin allergy. Applicants should be able to provide proof that they have a right to work in the UK at the time of their application. Applicants who are unable to provide this proof will not be considered.
Benefits
- Free Life Assurance
- Company Pension - salary sacrifice scheme
- Healthcare cash plan
- 32 days annual leave
- Wedding Leave
- Company Sick Pay
- Company Maternity / Paternity
- Paid bereavement leave
- Cycle to Work Scheme
- Tech Purchase Scheme
- Employee Savings scheme
- Employee well-being initiatives
- Employee Assistance Programme
- On-site free parking
- Subsidised Canteen Facilities
- Employee Perks scheme
- Employee Recognition scheme
- Career development opportunities
To Apply
Please forward your CV via the APPLY Now button below.
QA Compliance Microbiologist JBLE1_NI in Newry employer: Norbrook
As a QA Compliance Microbiologist at our Newry facility, you will join a dynamic team dedicated to maintaining the highest standards of cleanroom compliance and quality assurance. We pride ourselves on fostering a supportive work culture that prioritises employee well-being and professional growth, offering comprehensive benefits such as a generous annual leave policy, healthcare cash plan, and career development opportunities. With a commitment to continuous improvement and innovation, this role provides a unique opportunity to contribute to meaningful projects in a state-of-the-art environment while enjoying the perks of working in a collaborative and engaging workplace.
StudySmarter Expert Advice🤫
We think this is how you could land QA Compliance Microbiologist JBLE1_NI in Newry
✨Tip Number 1
Get to know the company culture! Before your interview, do a bit of digging into their values and work environment. This will help you tailor your responses and show that you're genuinely interested in being part of their team.
✨Tip Number 2
Practice makes perfect! Run through common interview questions with a friend or in front of the mirror. The more comfortable you are with your answers, the more confident you'll feel during the actual interview.
✨Tip Number 3
Show off your skills! Bring along examples of your previous work or projects that highlight your experience in cleanroom compliance and microbiology. This can really set you apart from other candidates.
✨Tip Number 4
Don’t forget to follow up! After your interview, send a quick thank-you email to express your appreciation for the opportunity. It’s a nice touch and keeps you fresh in their minds as they make their decision.
We think you need these skills to ace QA Compliance Microbiologist JBLE1_NI in Newry
Some tips for your application 🫡
Tailor Your CV:Make sure your CV reflects the skills and experiences that match the QA Compliance Microbiologist role. Highlight any relevant cleanroom experience and training roles you've had, as this will show us you're a great fit!
Show Off Your Attention to Detail:Since this role requires excellent attention to detail, make sure your application is free from typos and errors. A well-organised CV and cover letter will demonstrate your commitment to quality right from the start.
Be Clear About Your Experience:When detailing your past roles, be specific about your responsibilities and achievements, especially those related to aseptic techniques and compliance. We want to see how you’ve contributed to continuous improvement in previous positions.
Apply Through Our Website:We encourage you to apply directly through our website. It’s the easiest way for us to receive your application and ensures you’re considered for the role. Don’t miss out on this opportunity!
How to prepare for a job interview at Norbrook
✨Know Your Aseptic Practices
Make sure you brush up on your knowledge of aseptic techniques and cleanroom behaviours. Be ready to discuss how you've applied these practices in previous roles, as this will show your understanding of the job requirements.
✨Prepare for Compliance Questions
Expect questions about GMP requirements and regulatory standards. Familiarise yourself with the latest guidelines and be prepared to explain how you would ensure compliance in a cleanroom environment.
✨Showcase Your Training Experience
If you've had any experience in training others, highlight it! Discuss how you’ve delivered training sessions or supported continuous improvement projects, as this is a key part of the role.
✨Demonstrate Attention to Detail
During the interview, provide examples that showcase your attention to detail. Whether it's through past inspections or documentation, showing that you can identify and address deficiencies will set you apart.
