At a Glance
- Tasks: Review and ensure compliance of Batch Manufacturing Records in a dynamic production environment.
- Company: Join a leading pharmaceutical company committed to quality and innovation.
- Benefits: Enjoy medical, dental, vision insurance, retirement plans, and flexible vacation.
- Other info: Great opportunity for career growth in a supportive and collaborative team.
- Why this job: Make a real impact on product quality and safety in the pharmaceutical industry.
- Qualifications: Attention to detail, teamwork skills, and experience with quality systems are essential.
The predicted salary is between 30000 - 40000 £ per year.
The Batch Processing Record Reviewer is responsible for ensuring all batches processed in B750 Extraction Facility have Batch Manufacturing Records completed in compliance with requirements. This requires all processing steps to have been completed and documented with respect to ALCOA principles and all Critical Process Parameters (CPPs) having been met prior to approving the manufacturing review. Any deficiencies must be documented and where appropriate deviations raised and referenced. The Job Holder must ensure compliance with Health and Safety (H&S) and current Good Manufacturing Practices (cGMP) requirements at all times.
Responsibilities
- Perform production review of Batch Manufacturing Records as scheduled ensuring they are clear, complete and in compliance with company procedures, regulatory requirements and GMP requirements prior to release to QA.
- Lead and support departmental investigations (including deviations and complaints) ensuring that they are fully documented, that the root cause has been determined and that corrective and preventative actions have been introduced or initiated as agreed and on time.
- Report compliance failures or unusual trends.
- Authors and update batch documentation, standard operating procedures and associated forms.
- Ensure training records are kept up to date by taking personal responsibility for own training and ensuring all relevant training and competency assessments are complete before undertaking tasks unsupervised.
- Support delivery of strategic projects such as the introduction of Tulip incorporating improvements to Logbooks and introduction of Electronic Batch Records.
- Promote the importance of quality expectations throughout the department positively, challenging incorrect behaviours in others and acting as Point of Contact (POC) and ambassador for area of specialism.
- Work with all areas of the KSP Jazz Supply Team, B750 Production and QA, developing working relationships with them to help resolve (and prevent) issues.
- Perform GEMBAs of the processes; look for continuous improvement opportunities and support operational excellence initiatives.
Qualifications
- Working knowledge of Office IT packages including Microsoft Office.
- Excellent interpersonal skills and the ability to work as part of a team or independently.
- Excellent attention to detail and written communication skills.
- Ability to manage time/workload through effective prioritization.
- Experience working with an Enterprise Resource Planning (ERP) system is desirable.
- Proven experience in the use of Quality Systems and management of Quality events such as deviations, OOS, Change Control and CAPA in Pharmaceutical or other scientific related industry.
Education & Licenses
- Ideally holds qualifications gained in the pharmaceutical industry e.g., NVQs or similar.
Benefits
- Benefits offerings, including but not limited to, medical, dental and vision insurance, retirement savings plan, and flexible paid vacation.
Production Quality Specialist, Manufacturing (12 Month FTC). Job in Sittingbourne LilyLifestyle Jobs employer: Jazz Pharmaceuticals
At Jazz Pharmaceuticals, we pride ourselves on being an excellent employer, offering a supportive work culture that prioritises employee growth and development. Located in Sittingbourne, our team enjoys comprehensive benefits including medical, dental, and vision insurance, alongside a flexible paid vacation policy. We foster an environment of continuous improvement and collaboration, ensuring that every employee feels valued and empowered to contribute to our mission of delivering high-quality pharmaceutical products.
StudySmarter Expert Advice🤫
We think this is how you could land Production Quality Specialist, Manufacturing (12 Month FTC). Job in Sittingbourne LilyLifestyle Jobs
✨Tip Number 1
Network like a pro! Reach out to people in the industry, attend events, and connect on LinkedIn. You never know who might have the inside scoop on job openings or can put in a good word for you.
✨Tip Number 2
Prepare for interviews by researching the company and role thoroughly. Understand their values and how they align with your skills. This will help you answer questions confidently and show you're genuinely interested.
✨Tip Number 3
Practice makes perfect! Do mock interviews with friends or family to get comfortable with common questions. The more you practice, the more natural you'll feel when it’s time to shine.
✨Tip Number 4
Don’t forget to follow up after interviews! A quick thank-you email can leave a lasting impression and shows your enthusiasm for the position. Plus, it keeps you on their radar!
We think you need these skills to ace Production Quality Specialist, Manufacturing (12 Month FTC). Job in Sittingbourne LilyLifestyle Jobs
Some tips for your application 🫡
Tailor Your Application:Make sure to customise your CV and cover letter for the Production Quality Specialist role. Highlight your experience with Batch Manufacturing Records and compliance with GMP requirements, as this will show us you understand what we're looking for.
Show Off Your Attention to Detail:Since this role requires excellent attention to detail, be sure to demonstrate this in your application. Use clear and concise language, and double-check for any typos or errors before hitting send. We want to see that you can communicate effectively!
Highlight Relevant Experience:If you've worked with quality systems or have experience in the pharmaceutical industry, make it known! Share specific examples of how you've managed quality events or contributed to compliance, as this will resonate with us.
Apply Through Our Website:We encourage you to apply directly through our website. It’s the best way for us to receive your application and ensures you’re considered for the role. Plus, it shows us you're keen on joining our team!
How to prepare for a job interview at Jazz Pharmaceuticals
✨Know Your Batch Manufacturing Records
Make sure you understand the ins and outs of Batch Manufacturing Records. Familiarise yourself with ALCOA principles and Critical Process Parameters (CPPs) so you can confidently discuss how you ensure compliance during your review process.
✨Showcase Your Attention to Detail
During the interview, highlight specific examples where your attention to detail made a difference in your previous roles. Discuss how you’ve documented deficiencies and raised deviations, as this will demonstrate your commitment to quality and compliance.
✨Prepare for Team Dynamics
Since this role involves working closely with various teams, be ready to talk about your interpersonal skills. Share experiences where you’ve successfully collaborated with others to resolve issues or improve processes, showcasing your ability to be a team player.
✨Emphasise Continuous Improvement
Be prepared to discuss how you've contributed to continuous improvement initiatives in past positions. Mention any experience with GEMBAs or operational excellence projects, as this will show your proactive approach to enhancing quality and efficiency.
