At a Glance
- Tasks: Join our QA team to ensure product quality and compliance in exciting projects.
- Company: Piramal Pharma is a leading developer of biological reagents impacting millions daily.
- Benefits: Enjoy flexible working hours and opportunities for career growth in a supportive environment.
- Why this job: Be part of a mission-driven company that values your health and well-being while making a difference.
- Qualifications: Ideal candidates are detail-oriented, with a passion for quality assurance and compliance.
- Other info: Engage in audits and collaborate with stakeholders to enhance product quality.
The predicted salary is between 36000 - 60000 £ per year.
Piramal Pharma is a world-leading developer and manufacturer of high-quality biological reagents and is seeking a Quality Assurance officer to join their growing team in our QA department in Grangemouth.
The Quality Assurance officer will act as the Quality Assurance representative for campaign projects, ensuring accuracy and compliance of procedures, quality management system records, manufacturing batch records and associated testing.
Be the QA representative for new products and for change projects, dealing with aspects including review/approval of process instructions, change controls, deviations, investigations, validation, customer audits/quality requests, and material and product disposition.
The QA officer is expected to identify, escalate and work to address any GMP/GxP issues with potential impact to product quality or quality compliance.
Together we offer fantastic opportunities for committed employees to learn and develop their career with us. At Piramal , we research, develop, and supply Biopharma products and services that impact the lives of millions of people each day to make life better, and keep us safer. Your health and well-being matters to us and that’s why we offer you the flexibility to do what’s important to you whether that’s the ability to flex your start and finish times. Where possible, we support a working pattern that suits your lifestyle and helps you reach your ambitions.
Key Roles/Responsibilities
- QA primary point of contact (internal and external) for designated projects.
- Collaborate with internal and external stakeholders to ensure quality of all product related activities.
- Provide QA input to project activities including review and approval of change requests, specifications, Standard Operating Procedures, Manufacturing Procedures, Analytical Procedures and associated documentation.
- Participate in quality related investigations, assist in the development, approval and implementation of effective CAPA in order to resolve production, audit and customer issues.
- Participate in validation activities including approval of protocols and reports for analytical methods, manufacturing processes, analytical / production / packaging equipment and cleaning procedures
- Participate in the audits of suppliers and self-inspection of internal production and support functions as required
- Be involved in preparation for and successful completion of MHRA/FDA and other regulatory body audits.
- Coordinate quality disposition activities associated with designated materials and products.
- Verify manufacturing, laboratory and associated documentation prior to performing the relevant disposition of products. Where potential issues exist, these are to be highlighted to the QA manager.
- Promote and work to ensure compliance with all relevant GMP/GxP requirements.
- Support and lead as required, quality process improvements and quality management system improvements within the department and on site.
- Escalate any identified GMP/GxP areas of concern to Quality Management and QP.Warehouse on call team.
Quality Assurance Officer (Pharma) employer: Piramal Pharma Solutions
Contact Detail:
Piramal Pharma Solutions Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Quality Assurance Officer (Pharma)
✨Tip Number 1
Familiarize yourself with GMP/GxP regulations and standards. Understanding these guidelines is crucial for a Quality Assurance Officer, as they form the backbone of compliance in the pharmaceutical industry.
✨Tip Number 2
Network with professionals in the pharmaceutical quality assurance field. Attend industry conferences or join relevant online forums to connect with others who can provide insights and potentially refer you to job openings.
✨Tip Number 3
Gain experience with quality management systems and documentation practices. Familiarity with tools and software used in QA processes will give you an edge when applying for this role.
✨Tip Number 4
Prepare for potential interviews by reviewing common QA scenarios and how you would handle them. Being able to discuss your problem-solving approach in relation to quality issues will demonstrate your readiness for the position.
We think you need these skills to ace Quality Assurance Officer (Pharma)
Some tips for your application 🫡
Understand the Role: Take the time to thoroughly read the job description for the Quality Assurance Officer position at Piramal Pharma. Understand the key responsibilities and required qualifications to tailor your application accordingly.
Highlight Relevant Experience: In your CV and cover letter, emphasize any previous experience in quality assurance, particularly in the pharmaceutical industry. Mention specific projects or tasks that align with the responsibilities outlined in the job description.
Showcase Your Skills: Make sure to highlight skills that are crucial for the role, such as knowledge of GMP/GxP regulations, experience with quality management systems, and your ability to conduct audits and investigations. Use concrete examples to demonstrate these skills.
Craft a Compelling Cover Letter: Write a personalized cover letter that explains why you are interested in the Quality Assurance Officer position at Piramal Pharma. Discuss how your background and skills make you a great fit for the team and how you can contribute to their mission.
How to prepare for a job interview at Piramal Pharma Solutions
✨Understand GMP/GxP Standards
Make sure you have a solid understanding of Good Manufacturing Practices (GMP) and Good Laboratory Practices (GxP). Be prepared to discuss how these standards apply to the role and provide examples of how you've ensured compliance in previous positions.
✨Showcase Your Attention to Detail
As a Quality Assurance Officer, attention to detail is crucial. Prepare to share specific instances where your meticulous nature helped identify issues or improve processes. Highlight any experience with documentation review and approval.
✨Collaborative Mindset
The role requires collaboration with various stakeholders. Be ready to discuss how you've successfully worked with cross-functional teams in the past. Emphasize your communication skills and ability to build relationships to ensure quality across projects.
✨Prepare for Regulatory Questions
Since the position involves audits and regulatory compliance, familiarize yourself with the MHRA/FDA requirements. Be prepared to answer questions about your experience with audits and how you've handled regulatory challenges in previous roles.