At a Glance
- Tasks: Support quality systems and compliance in a global pharmaceutical environment.
- Company: Join a leading pharmaceutical organisation dedicated to innovative medicines.
- Benefits: Hybrid work model, competitive salary, and opportunities for professional growth.
- Other info: Collaborative team environment with a focus on continuous improvement.
- Why this job: Make a real impact on patient outcomes through quality assurance.
- Qualifications: Degree in science or healthcare, with experience in GCP and GVP.
The predicted salary is between 45000 - 55000 £ per year.
Location: Bracknell (Hybrid)
Company: Our client is a global pharmaceutical organisation focused on developing and delivering innovative medicines that improve patient outcomes worldwide. Operating across multiple therapeutic areas.
We are seeking an experienced Senior Quality Associate to support the implementation and oversight of quality systems and compliance activities across regional business operations. This role will work closely with cross-functional teams to ensure alignment between global quality standards and local regulatory requirements within a regulated pharmaceutical environment.
Key Responsibilities- Quality Systems Management
- Support the development, review, and maintenance of regional quality system documentation, procedures, and templates.
- Provide guidance on regulatory requirements, quality standards, and business process compliance.
- Manage deviations, change controls, notifications to management (NTMs), and CAPA activities.
- Conduct root cause investigations and support implementation of corrective and preventive actions.
- Ensure effective application of enterprise quality systems and continuous compliance across the business.
- Participate in quality self-assessments and external party oversight activities.
- Quality Oversight & Compliance
- Monitor compliance with quality procedures and proactively identify process improvements and risk mitigation opportunities.
- Support implementation and tracking of regional quality plans and compliance actions.
- Analyse quality trends, identify gaps, and recommend corrective actions where required.
- Provide input into risk assessments, audit planning, and quality improvement initiatives.
- Drive continuous improvement and promote best practices across teams and functions.
- Audits & Inspections
- Coordinate and support audit and inspection readiness activities, including document preparation and stakeholder coordination.
- Manage audit responses and ensure timely completion of CAPA actions arising from inspections or audits.
- Support front room/back room activities during regulatory inspections.
- Cross-Functional Collaboration
- Act as a key quality contact for assigned business areas.
- Partner with stakeholders to strengthen quality controls and compliance processes.
- Collaborate with global and regional quality teams to share knowledge and improve operational effectiveness.
- Contribute to business and quality-related projects as required.
- Bachelor’s or Master’s degree in a science or healthcare-related discipline.
- Previous experience within Quality, Regulatory Affairs, Clinical Development, Pharmacovigilance, or related GxP environments.
- Experience in GCP, GVP.
- Experience supporting audits and regulatory inspections.
- Excellent communication, analytical, and problem-solving skills.
- Ability to manage multiple priorities within a fast-paced, regulated environment.
- Experience working within global or cross-functional teams is advantageous.
Locations
Senior Quality Specialist (GCP and GVP) in Basingstoke, Hampshire employer: Planet Pharma
As a leading global pharmaceutical organisation, our client offers an exceptional work environment in Bracknell, where innovation meets collaboration. Employees benefit from a hybrid working model, fostering a healthy work-life balance while engaging in meaningful projects that directly impact patient outcomes. With a strong emphasis on professional development and continuous improvement, this role provides ample opportunities for growth within a supportive and dynamic team culture.
StudySmarter Expert Advice🤫
We think this is how you could land Senior Quality Specialist (GCP and GVP) in Basingstoke, Hampshire
✨Tip Number 1
Network like a pro! Reach out to your connections in the pharmaceutical industry, especially those who work in quality roles. A friendly chat can lead to insider info about job openings or even a referral.
✨Tip Number 2
Prepare for interviews by brushing up on GCP and GVP regulations. We want you to be the go-to person for quality standards, so show off your knowledge and experience during those crucial conversations.
✨Tip Number 3
Don’t just wait for job alerts! Actively search for opportunities on our website and apply directly. The more proactive you are, the better your chances of landing that Senior Quality Specialist role.
✨Tip Number 4
Follow up after interviews with a thank-you note. It’s a simple gesture that shows your enthusiasm for the role and keeps you fresh in the interviewer's mind. Plus, it’s a great way to reiterate your fit for the position!
We think you need these skills to ace Senior Quality Specialist (GCP and GVP) in Basingstoke, Hampshire
Some tips for your application 🫡
Tailor Your CV:Make sure your CV is tailored to the Senior Quality Associate role. Highlight your experience in quality systems, compliance activities, and any relevant GCP or GVP experience. We want to see how your background aligns with what we're looking for!
Craft a Compelling Cover Letter:Your cover letter is your chance to shine! Use it to explain why you're passionate about quality assurance in the pharmaceutical industry. Share specific examples of how you've contributed to quality improvements in past roles – we love a good story!
Showcase Your Skills:Don’t forget to highlight your analytical and problem-solving skills in your application. Mention any experience you have with audits, inspections, or managing deviations. We’re keen on candidates who can demonstrate their ability to drive continuous improvement.
Apply Through Our Website:We encourage you to apply through our website for the best chance of getting noticed. It’s super easy, and you’ll be able to keep track of your application status. Plus, we love seeing applications come directly from our site!
How to prepare for a job interview at Planet Pharma
✨Know Your Quality Standards
Make sure you brush up on GCP and GVP guidelines before the interview. Understanding these standards will not only show your expertise but also demonstrate your commitment to quality in a regulated environment.
✨Prepare for Scenario Questions
Expect questions that ask how you've handled deviations or CAPA activities in the past. Prepare specific examples that highlight your problem-solving skills and ability to implement corrective actions effectively.
✨Showcase Your Cross-Functional Experience
Since this role involves collaboration with various teams, be ready to discuss your experience working with cross-functional groups. Highlight any successful projects where you partnered with stakeholders to improve quality controls.
✨Ask Insightful Questions
At the end of the interview, don’t forget to ask questions that show your interest in the company’s quality systems and compliance processes. This could include inquiries about their approach to continuous improvement or how they handle audit readiness.
