At a Glance
- Tasks: Assist in leading production services and training staff in a dynamic environment.
- Company: Join MAC, a global leader in Contract Research with a mission to enhance human health.
- Benefits: Enjoy health insurance, eye care vouchers, free parking, and 25 days annual leave.
- Other info: Great career growth opportunities in a supportive and professional team.
- Why this job: Make a real impact in the healthcare sector while developing your skills.
- Qualifications: Knowledge of Good Manufacturing Practice and Good Clinical Practice is essential.
The predicted salary is between 36000 - 44000 £ per year.
MAC is a full-service global Contract Research Organisation (CRO).
We also own a network of research sites.
Our mission is to serve with honesty and integrity to make an outstanding contribution to human health.
We have an exciting opportunity for an Assistant Production Manager to join our dedicated team in Manchester.
FOCUS OF THE JOB
- Named as a “Supervisor of Production” on the MHRA MIA (IMP) licence.
- To work harmoniously with the Production Manager in an assistive role.
- To assist in the leading, delivery and evaluation of production services including aseptic services.
- Assist in training of production staff.
- To liaise with staff including the Medical Director, PI (Principal Investigator), Sub- Investigators, Site Directors, Feasibility/Proposals, Project Managers and CTAs, regarding requirements for studies of Investigational Medicinal Product (IMP) / commercial and comparator.
- To liaise with sponsors, vendors and customers for pharmacy production queries and guidance.
- To act as primary contact for designated trials and Production Manager as required.
KEY SKILLS, KNOWLEDGE AND QUALIFICATIONS REQUIRED
- Good, current knowledge of Good Manufacturing Practice with continued CPD
- Good, current knowledge of Good Clinical Practice with continued CPD
RESPONSIBILITIES
- Ensure compliance of the Manufacturing Unit with EU GMP.
- Ensure that products are produced and stored according to the appropriate documentation so that they reach the appropriate standards of quality.
- Assist in approving the instructions relating to production operations and ensure their strict implementation.
- Ensuring that the production records are evaluated and signed by an authorised person before they are sent to Quality Control (QC) Department.
- Assist in checking the maintenance of the department, premises and equipment.
- Ensuring that the appropriate equipment and process validations are carried out to GMP standards.
- Assist in the required initial and continuing training of department personnel.
- Assist in the authorisation of written procedures and other documents, including amendments.
- Ensure the monitoring and control of the manufacturing environment.
- Ensure plant hygiene standards are maintained.
- Assist in the approval and monitoring of suppliers of materials.
- Assist in the approval and monitoring of contract manufacturers and providers of other GMP related outsourced activates.
- The designation and monitoring of storage condition of materials and products.
- Responsible for paper documentation and electronic record retention.
- Assist in the monitoring of compliance with the requirements of Good Manufacturing Practice.
- Assist in the inspection, investigation, and taking of samples, in order to monitor factors which may affect product quality.
- Active in management reviews of processes performance, product quality and of the quality management system and advocating continual improvement.
- Ensuring that a timely and effective communication and escalation process exists to raise quality issues to the appropriate levels of management.
- Compliance with MAC health and Safety policy.
- Compliance with MAC policy on equality and diversity.
- To maintain professional qualifications required for the role, including continuous personal development.
- To work to the requirements of SI 2004 no 1031 and amendments thereof, which includes Good Clinical Practice.
- To work according to MAC SOPs, guidelines and policies.
- To work according to current data protection standards and practice good information management. Maintenance of strict confidentiality of patient and business-related data.
- To maintain a high level of initiative and personal responsibility, liaising appropriately with team members and managers to ensure your job role is efficiently carried out.
- To support the aims of MAC and to represent MAC appropriately in a professional way to all our customers.
BENEFITS
- Health Insurance
- Eye Care Vouchers
- Free onsite parking
- 25 days annual leave (increasing in increments to 30 days after 6 years’ service)
- Your birthday off work
Please email maccareers@macplc. com should you require any special arrangements or reasonable adjustments to be made throughout this selection process.
This will enable us to accommodate your request as necessary.
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Assistant Production Manager employer: MAC Clinical Research
MAC Clinical Research is an excellent employer that fosters a supportive and collaborative work culture in the heart of Blackpool. With a strong focus on employee development, we offer numerous growth opportunities and a flexible hybrid working model that promotes work-life balance. Join us to be part of a team that values your contributions and encourages meaningful engagement in the HR field.
StudySmarter Expert Advice🤫
We think this is how you could land Assistant Production Manager
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We think you need these skills to ace Assistant Production Manager
Some tips for your application 🫡
Showcase Your Relevant Experience:When applying for a role in the pharmaceutical industry, it's crucial to highlight any relevant experience you have. Whether that's internships, lab work, or even related coursework, make sure to weave this into your CV and cover letter. We want to see how your background aligns with the role you're applying for at MAC Clinical Research!
Emphasise Your Understanding of Regulations:The pharmaceutical industry is heavily regulated, so it's important to indicate your familiarity with industry standards and regulations. In your cover letter, mention any training or certifications you've received that are relevant, or discuss projects where you’ve navigated compliance. This will show MAC Clinical Research that you're not just a fit for the job but also a safety-conscious candidate!
Tailor Your CV to Be Result-Driven:Craft your CV to highlight quantifiable achievements, especially if you have previous roles in pharmaceuticals or related fields. Use metrics to demonstrate your impact, such as improved processing times or successful project completions while working on trials. This analytical approach will resonate well with hiring managers at MAC Clinical Research!
Convey Your Passion for the Industry:In your cover letter, express why you are passionate about working in the pharmaceutical sector. Whether it’s your desire to contribute to groundbreaking drug research or improve patient outcomes, let it shine through! At MAC Clinical Research, we value candidates who are truly enthusiastic about their work—you might just stand out from the crowd.
How to prepare for a job interview at MAC Clinical Research
✨Understand the Science
Make sure you brush up on key pharmaceutical concepts and recent developments in the industry. You might get asked some technical questions during the interview at MAC Clinical Research that show your grasp of drug development processes or regulatory requirements, so be ready to discuss them clearly.
✨Showcase Relevant Experience
If you have any hands-on experience or internships in a laboratory setting, be sure to highlight these in your responses. Think about the projects you worked on, the methodologies you used, and the impact you made. It's all about telling a story that connects your background to the role you're applying for.
✨Know Their Products
Take some time to familiarise yourself with MAC Clinical Research’s product range and recent breakthroughs. Understanding their portfolio not only shows your enthusiasm for the role but also allows you to ask insightful questions that demonstrate your interest in actively contributing to their projects.
✨Be Ready for Regulatory Scenarios
In a full-time pharmaceutical role, understanding the regulatory landscape is crucial. Prepare for situational questions that may test your problem-solving skills concerning compliance and safety standards. You could be asked how you'd handle a hypothetical issue regarding a drug’s market release, so think through your approach.
