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- Tasks: Support quality assurance processes and ensure compliance with GMP standards.
- Company: Join a leading company in the pharmaceutical industry focused on quality and compliance.
- Benefits: Enjoy a 9-month role with potential extension and hands-on experience in a dynamic environment.
- Why this job: Be part of a team driving continuous improvement and making a real impact on product quality.
- Qualifications: Bachelor's degree in Biology or related field; strong attention to detail and communication skills required.
- Other info: This is a fully onsite position located in Slough, Berkshire.
The predicted salary is between 36000 - 60000 £ per year.
Role Purpose & Scope:
Enable site operations performance by managing and supporting GMP issues through QMS processes, site governance and senior QA leadership. Ensure that quality is maintained at an appropriate level meeting customer and regulatory expectations and enable the Slough Site to deliver to relevant targets. This will be achieved by assessing compliance with site PQS and principles of GMP auditing documentation generated during manufacturing processes, development and laboratory processes and where required escalating non-compliance through the PQS, site governance mechanisms and senior QA Leadership. Supporting Senior QA leadership to drive continuous improvement. Maintaining compliance with Regulatory Authorities requirements, Global Quality standards and client’s Customer expectations.
Key Responsibilities:
- To provide shoulder to shoulder review of documentation generated during manufacturing processes, development and laboratory processes.
- Advise areas of support on best practice for document completion, review and follow up actions/ escalate if required.
- Acting as a point of contact for general queries relating to Quality and escalating as required.
- Expand and utilize knowledge of quality procedures to identify and report non-conformances and resolve issues arising in the area via interaction with the relevant personnel.
- Utilize knowledge of GMP and quality processes within the functional areas to manage and escalate major and critical compliance issues through the site QMS processes e.g. deviations and CAPAs.
- To actively identify, suggest and participate in continuous improvement activities.
- Mentor and coach business partners in cGMP practice to maintain and develop a cGMP environment.
- Maintain and promote a state of audit readiness.
- Actively suggest, initiate, participate and contribute to PQS process improvement initiatives and projects.
Key Stakeholders:
- Manufacturing
- Material Science and Technology (MSAT)
- Supply Chain
Required Skills & Competencies:
- IT literate (MS Office – Word, Explorer, Excel, Access, Outlook) familiarity with database entries.
- Verbal and written communication skills.
- Risk based decision making.
- PQS experience.
- Accurate data entry skills, high attention to detail.
- Demonstrated workload prioritization skills, decision making and scheduling skills.
- Ability to meet strict deadlines.
- Good organizational and planning skills.
Education/Degree:
Required: Bachelors of Science (or equivalent experience) Field of Study Biology or related field.
Performance and Quality assurance Specialist employer: LanceSoft UK
Contact Detail:
LanceSoft UK Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Performance and Quality assurance Specialist
✨Tip Number 1
Familiarise yourself with Good Manufacturing Practices (GMP) and Quality Management Systems (QMS). Understanding these concepts will not only help you in interviews but also demonstrate your commitment to quality assurance.
✨Tip Number 2
Network with professionals in the pharmaceutical and biotechnology sectors. Attend industry events or join relevant online forums to connect with people who can provide insights into the role and potentially refer you.
✨Tip Number 3
Prepare to discuss specific examples of how you've contributed to quality improvement initiatives in previous roles. Highlighting your hands-on experience will set you apart from other candidates.
✨Tip Number 4
Research StudySmarter and our values, especially regarding quality and compliance. Tailoring your conversation to align with our mission will show that you're genuinely interested in being part of our team.
We think you need these skills to ace Performance and Quality assurance Specialist
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights relevant experience and skills that align with the role of a Performance and Quality Assurance Specialist. Emphasise your knowledge of GMP, quality processes, and any previous QA roles.
Craft a Strong Cover Letter: Write a cover letter that specifically addresses the key responsibilities mentioned in the job description. Explain how your background in biology or related fields equips you to manage GMP issues and support continuous improvement.
Highlight Relevant Skills: In your application, clearly outline your IT literacy, communication skills, and attention to detail. Provide examples of how you've successfully managed compliance issues or contributed to process improvements in past roles.
Proofread Your Application: Before submitting, carefully proofread your CV and cover letter for any errors. Ensure that your documents are well-organised and clearly formatted, as this reflects your attention to detail and professionalism.
How to prepare for a job interview at LanceSoft UK
✨Know Your GMP and PQS Inside Out
Make sure you have a solid understanding of Good Manufacturing Practices (GMP) and the Quality Management System (QMS). Be prepared to discuss how these principles apply to the role and provide examples from your past experiences.
✨Showcase Your Attention to Detail
As a Performance and Quality Assurance Specialist, attention to detail is crucial. Bring examples of how you've maintained high standards in documentation and compliance in previous roles. Highlight any specific instances where your attention to detail made a significant impact.
✨Prepare for Scenario-Based Questions
Expect questions that assess your problem-solving skills and decision-making abilities. Prepare scenarios where you had to identify non-conformances or resolve compliance issues, and explain your thought process and actions taken.
✨Demonstrate Your Communication Skills
Effective communication is key in this role. Be ready to discuss how you've successfully collaborated with various stakeholders, such as manufacturing and supply chain teams. Practice articulating your thoughts clearly and concisely.
