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- Tasks: Support GMP issues and ensure quality compliance in manufacturing processes.
- Company: Join a leading company in the pharmaceutical industry focused on quality assurance.
- Benefits: Gain hands-on experience with potential for role extension and professional growth.
- Why this job: Be part of a dynamic team driving continuous improvement and maintaining high-quality standards.
- Qualifications: Bachelor's degree in Biology or related field; strong attention to detail required.
- Other info: This is a fully onsite position located in Slough, Berkshire.
The predicted salary is between 36000 - 60000 £ per year.
Location: Slough, Berkshire SL1 4DX
Duration: 9-month role with potential to extend
Fully onsite position
Description:
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
GMP Quality Assurance Associate employer: LanceSoft UK
Contact Detail:
LanceSoft UK Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land GMP Quality Assurance Associate
✨Tip Number 1
Familiarise yourself with GMP regulations and quality assurance processes. Understanding the specific requirements and standards that govern the industry will help you demonstrate your knowledge during interviews and discussions.
✨Tip Number 2
Network with professionals in the pharmaceutical and quality assurance sectors. Attend industry events or join relevant online forums to connect with people who can provide insights into the role and potentially refer you to opportunities at StudySmarter.
✨Tip Number 3
Prepare to discuss your experience with document review and compliance management. Be ready to share specific examples of how you've handled non-conformances or contributed to continuous improvement initiatives in previous roles.
✨Tip Number 4
Showcase your IT skills, particularly with MS Office and database management. Being proficient in these tools is crucial for the role, so consider highlighting any relevant projects or experiences where you've successfully used these applications.
We think you need these skills to ace GMP Quality Assurance Associate
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights relevant experience in GMP and Quality Assurance. Emphasise any specific roles or projects where you managed compliance, documentation, or quality processes.
Craft a Strong Cover Letter: In your cover letter, explain why you're interested in the GMP Quality Assurance Associate role. Mention how your skills align with the key responsibilities and required competencies outlined in the job description.
Highlight Relevant Skills: Clearly showcase your IT literacy, attention to detail, and communication skills in your application. Provide examples of how you've used these skills in previous roles, especially in relation to quality assurance.
Proofread Your Application: Before submitting, thoroughly proofread your application for any spelling or grammatical errors. A polished application reflects your attention to detail, which is crucial for a role in quality assurance.
How to prepare for a job interview at LanceSoft UK
✨Understand GMP Principles
Make sure you have a solid grasp of Good Manufacturing Practices (GMP) and how they apply to quality assurance. Be prepared to discuss specific examples of how you've implemented or adhered to these principles in previous roles.
✨Familiarise Yourself with QMS Processes
Research the Quality Management System (QMS) processes relevant to the role. Being able to articulate your understanding of these processes and how they ensure compliance will demonstrate your readiness for the position.
✨Prepare for Scenario-Based Questions
Expect questions that assess your problem-solving skills and decision-making abilities. Prepare to discuss scenarios where you identified non-conformances or contributed to continuous improvement initiatives.
✨Showcase Your Communication Skills
Since the role involves advising and mentoring, highlight your verbal and written communication skills. Be ready to provide examples of how you've effectively communicated complex information to various stakeholders.
