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- Tasks: Join our team to ensure quality in clinical supplies and manage investigations.
- Company: Pfizer is a leading pharmaceutical company dedicated to transforming patients' lives through innovative solutions.
- Benefits: Enjoy a hybrid work model, flexible hours, and a culture that values work-life balance.
- Why this job: Make a real impact on patient safety while working in a supportive and inclusive environment.
- Qualifications: Bachelor's degree preferred with 3+ years in a cGMP pharmaceutical setting.
- Other info: We celebrate diversity and are committed to supporting all employees, including those with disabilities.
The predicted salary is between 36000 - 60000 £ per year.
Quality Assurance Senior Associate page is loaded## Quality Assurance Senior Associatelocations: United Kingdom – Sandwichtime type: 全职posted on: 今天发布job requisition id: 4940627**Use Your Power for Purpose**Every day, Pfizer’s unwavering commitment to quality ensures the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is both flexible and innovative, always putting the patient first. Whether you are involved in development, maintenance, compliance, or research analysis, your contribution directly impacts patients.**ROLE SUMMARY**This Quality position is considered a global position and reports into the Global Clinical Supply Quality Assurance (GCS QA) Lead for Clinical Complaints and Investigations, within Pharm Sci Operation Quality (PSOQ) responsible for supporting Pharmaceutical Sciences.This Senior (Sr) Associate Quality Assurance position will primarily support the GMP/GCP interface specialty team within GCS QA and may lead to opportunities to move or rotate into the wider areas of GCS QA in alignment with Development Planning and/or Business need.This Sr Associate will be responsible for leveraging strong and collaborative partnerships with colleagues across PSOQ, Global Clinical Supplies / Clinical Development Operations, other Worldwide Research and Development organizations and PGS to support the management primarily for the following areas: Clinical Complaints and Investigation management.In addition, would be required to support Inspection/Audit readiness, data analysis and development and management of Spotfire and SharePoint platforms, also responsible for developing and enhancing processes to continuously improve and streamline existing quality processes to support activities, with knowledge and skills contributing towards the goals and objectives of the team.**ROLE RESPONSIBILITIES**Perform a range of duties within the GCS QA Clinical Complaints and Investigation team, associated with Quality Management Systems oversight, Quality Operational role for Clinical Complaints, Investigations and may be required to support Inspection/Audit readiness , for which Duties may include some or all the following, at various times, depending on experience and job assignment:* Responsible for leading /supporting the author, review, and approval of related GMP deviations & product quality investigations and provide oversight to the timely closeout and effective investigation of clinical supplies, CAPA effectiveness, trending, and metrics.* Responsible for leading /supporting the author, review, and approval of clinical complaints, ensuring timely closeout, providing complaint management oversight for trending and metrics, CAPA effectiveness.* Escalate issues as appropriate to the Quality Assurance Lead in a timely manner, with responsibilities for generating Notifications to Management/ Issue Escalations.* May be required to participate/ support PSQRT/AQRT activities and outcomes.* Audit/Inspection Support, collaborate with Global Clinical Supply, Pharm Sci Operation Quality and other groups in Worldwide Research and Development to support regulatory agency inspections, Regulatory Quality Assurance and Internal audits / Inspections.* Applies skills and knowledge to Support continuous improvement in the support model and management of Good Manufacturing Practices (GMP) and Good Clinical Practices (GCP) activities for the investigational medicinal product process through partnerships with Global Clinical Supply and the wider Clinical Development Operations.* Support the development and management for Spotfire and SharePoint platforms, using these for data analysis, team documentation repository, plus as a communication tool.* Takes appropriate risks to Streamline compliance and simplify procedural and other requirements to ensure ease of following program requirements.* Able to operate independently in ambiguous situations.* Ensure effective internal networking to develop and maintain business partner relationships with internal colleagues.* Takes responsibility for a portion of the Team’s milestones/deliverables.* Utilize and share learnings from audits/inspections to advance inspection readiness.**Here Is What You Need** (Minimum Requirements)* Preferred bachelor’s degree (B.S.)* 3 + Years’ experience* Relevant work experience in a cGMP pharmaceutical Environment* knowledge of cGMP regulations and the principles/concepts of relevant quality systems and regulatory compliance.* Comprehensive and broad knowledge of quality systems.* Demonstrated experience in supporting continuous improvement projects.* Proven leadership, accountability, and demonstrated excellent interpersonal, listening, communication, negotiation, influencing, organizing and problem-solving capabilities.* Proven ability to function autonomously in a matrix model and in a team environment.* Proactive approach and strong critical thinking skills**Bonus Points If You Have** (Preferred Requirements)* Knowledge of GCP regulations, principles, and concepts* Quality Mindset* Computer skills in MS Office applications and a good understanding of enterprise systems such as Quality Tracking System, eQMS, and Documentum platforms Work Location Assignment: Hybrid Purpose **Breakthroughs that change patients\’ lives**… At Pfizer we are a patient centric company, guided by our four values: courage, joy, equity and excellence. Our breakthrough culture lends itself to our dedication to transforming millions of lives. Digital Transformation StrategyOne bold way we are achieving our purpose is through our company wide digital transformation strategy. We are leading the way in adopting new data, modelling and automated solutions to further digitize and accelerate drug discovery and development with the aim of enhancing health outcomes and the patient experience.Flexibility We aim to create a trusting, flexible workplace culture which encourages employees to achieve work life harmony, attracts talent and enables everyone to be their best working self. Let’s start the conversation! Equal Employment Opportunity We believe that a diverse and inclusive workforce is crucial to building a successful business. As an employer, Pfizer iscommitted to celebratingthis,in all itsforms – allowing for us to be as diverse as the patients and communities we serve. Together, we continue to build a culture that encourages, supports and empowers our employees.DisAbility ConfidentWe are proud to be a Disability Confident Employer and we encourage you to put your best self forward with the knowledge and trust that we will make any reasonable adjustments necessary to support your application and future career. Our mission is unleashing the power of our people, especially those with unique superpowers. Your journey with Pfizer starts here!Quality Assurance and Control #J-18808-Ljbffr
Quality Assurance Senior Associate employer: Pfizer
Contact Detail:
Pfizer Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Quality Assurance Senior Associate
✨Tip Number 1
Network with professionals in the pharmaceutical industry, especially those working in quality assurance. Attend relevant conferences or webinars to connect with potential colleagues and learn about the latest trends in GMP and GCP.
✨Tip Number 2
Familiarise yourself with the specific quality management systems used at Pfizer. Understanding their processes and tools, such as Spotfire and SharePoint, can give you an edge during interviews and demonstrate your proactive approach.
✨Tip Number 3
Prepare to discuss your experience with continuous improvement projects. Be ready to share specific examples of how you've contributed to enhancing quality processes in previous roles, as this aligns closely with the responsibilities of the position.
✨Tip Number 4
Showcase your leadership and problem-solving skills during the interview process. Be prepared to discuss situations where you've had to operate independently or lead a team through challenges, as these qualities are highly valued in this role.
We think you need these skills to ace Quality Assurance Senior Associate
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights relevant experience in quality assurance, particularly in cGMP environments. Use specific examples that demonstrate your understanding of quality systems and regulatory compliance.
Craft a Compelling Cover Letter: Write a cover letter that connects your skills and experiences to the role of Quality Assurance Senior Associate. Emphasise your leadership abilities and proactive approach, and explain how you can contribute to Pfizer's mission.
Highlight Relevant Skills: In your application, clearly outline your knowledge of GMP and GCP regulations, as well as your experience with continuous improvement projects. Mention any specific tools or platforms you are familiar with, such as Spotfire or SharePoint.
Showcase Your Problem-Solving Abilities: Provide examples in your application that illustrate your critical thinking and problem-solving skills. Discuss situations where you successfully navigated challenges in quality assurance or compliance.
How to prepare for a job interview at Pfizer
✨Understand GMP and GCP Regulations
Make sure you have a solid grasp of Good Manufacturing Practices (GMP) and Good Clinical Practices (GCP). Be prepared to discuss how these regulations impact quality assurance processes, as this knowledge is crucial for the role.
✨Showcase Your Problem-Solving Skills
Prepare examples from your past experience where you've successfully identified and resolved quality issues. Highlight your critical thinking abilities and how they contributed to continuous improvement in your previous roles.
✨Demonstrate Effective Communication
Since the role involves collaboration with various teams, practice articulating your thoughts clearly. Be ready to discuss how you've effectively communicated complex information to different stakeholders in the past.
✨Familiarise Yourself with Data Analysis Tools
As the position requires managing platforms like Spotfire and SharePoint, brush up on your data analysis skills. Be prepared to discuss any relevant experience you have with these tools or similar software.
