At a Glance
- Tasks: Ensure compliance with quality standards and support regulatory processes in the pharmaceutical industry.
- Company: Join Piramal Pharma Solutions, a leader in drug development and manufacturing.
- Benefits: Gain valuable experience in a dynamic environment with opportunities for growth.
- Other info: Collaborative culture with a focus on continuous improvement and innovation.
- Why this job: Make a real impact on healthcare by ensuring quality in life-saving products.
- Qualifications: Degree in a related field and 2 years of QA experience required.
The predicted salary is between 29700 - 36300 £ per year.
Piramal Pharma Solutions is a contract development and manufacturing organization (CDMO), offering end-to-end development and manufacturing solutions across the drug life cycle. We serve our clients through a globally integrated network of facilities in North America, Europe and Asia. This enables us to offer a comprehensive range of services including Drug Discovery Solutions, Process & Pharmaceutical Development services, Clinical Trial Supplies, Commercial supply of APIs and Finished dosage forms. We also offer specialized services like development and manufacture of Highly Potent APIs and Antibody Drug Conjugation. Our capability as an integrated service provider and experience with various technologies enables us to serve Innovator and Generic companies worldwide.
The role of the QA Compliance Officer is to support governance and compliance of the Pharmaceutical Quality Management System (PQS) at Piramal Grangemouth and maintenance of Regulatory Registrations/Licenses/Certifications. The role will support the site and related functions in maintaining compliance with GxP regulations and applicable quality guidelines, including, but not limited to UK/EU/US GMP/GDP, ICH and other region specific guidance. The individual will have support key quality system elements and compliance improvements, working closely with relevant stakeholders on site.
Key Roles/Responsibilities:
- Supporting key quality system elements, including activities relating to QMS monitoring, Qualification of Vendors, Audits (Self-Inspections, Vendor Audits, Customer Audits).
- Support updates to regulatory agency registrations as applicable.
- Support tracking of site compliance commitments and follow up actions.
- Working with the wider site functions to drive down out of compliance events and implement quality improvements.
- Support and track regulatory findings and trends that may lead into a focus of regulatory inspections.
- Support review of procedures and other QMS related documentation according to internal guidelines and UK/EU/US/ICH and other region specific guidance.
- Lead Quality Management Review meetings highlighting GxP areas of concern and working to support and track actions that are to be taken.
- Support quality related investigations, assist in the development and approval of effective CAPA in order to resolve product, audit and customer issues.
- Support effective pre-audit preparation and post audit follow up of customer audits and regulatory inspections.
- Escalate any significant breach of quality or regulatory compliance to Quality Management.
- Maintain productive working relationships with other site personnel and stakeholders.
Key Competencies:
- Attention to detail
- Problem solving skills
- Excellent communication skills
- Proficient in using Microsoft Office based applications - PowerPoint, MS Excel, MS Word, etc.
Essential Qualification:
College or Degree qualified in a related scientific, business, process/industrial engineering discipline.
Relevant Experience:
At least 2 years’ experience within Quality Assurance working to GMP. Experience of performing self-inspections or audits of 3rd party suppliers (GMP material manufacturing/testing laboratories, API or Drug Product manufacturing facilities). Experience of working within a Quality Management System e.g. completing or reviewing QMS documentation (SOPs/Deviations/Investigations/CAPA). Certified Auditor Training. Experience working on activities associated with supplier/vendor/material approval. Experience of supporting activities relating to audits and/or regulatory inspections.
QA Compliance Officer in Grangemouth employer: Piramal Pharma
Piramal Pharma Solutions is an exceptional employer, offering a dynamic work environment in Grangemouth where innovation and teamwork thrive. With a strong commitment to employee development, we provide ample opportunities for growth and skill enhancement, ensuring that our Maintenance Engineers are equipped to tackle exciting challenges while contributing to the success of our engineering systems. Our culture prioritises safety, collaboration, and excellence, making it a rewarding place to build a meaningful career.
StudySmarter Expert Advice🤫
We think this is how you could land QA Compliance Officer in Grangemouth
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We think you need these skills to ace QA Compliance Officer in Grangemouth
Some tips for your application 🫡
Showcase Your Relevant Experience:When applying for a role in the pharmaceutical industry, it's crucial to highlight any relevant experience you have. Whether that's internships, lab work, or even related coursework, make sure to weave this into your CV and cover letter. We want to see how your background aligns with the role you're applying for at Piramal Pharma!
Emphasise Your Understanding of Regulations:The pharmaceutical industry is heavily regulated, so it's important to indicate your familiarity with industry standards and regulations. In your cover letter, mention any training or certifications you've received that are relevant, or discuss projects where you’ve navigated compliance. This will show Piramal Pharma that you're not just a fit for the job but also a safety-conscious candidate!
Tailor Your CV to Be Result-Driven:Craft your CV to highlight quantifiable achievements, especially if you have previous roles in pharmaceuticals or related fields. Use metrics to demonstrate your impact, such as improved processing times or successful project completions while working on trials. This analytical approach will resonate well with hiring managers at Piramal Pharma!
Convey Your Passion for the Industry:In your cover letter, express why you are passionate about working in the pharmaceutical sector. Whether it’s your desire to contribute to groundbreaking drug research or improve patient outcomes, let it shine through! At Piramal Pharma, we value candidates who are truly enthusiastic about their work—you might just stand out from the crowd.
How to prepare for a job interview at Piramal Pharma
✨Understand the Science
Make sure you brush up on key pharmaceutical concepts and recent developments in the industry. You might get asked some technical questions during the interview at Piramal Pharma that show your grasp of drug development processes or regulatory requirements, so be ready to discuss them clearly.
✨Showcase Relevant Experience
If you have any hands-on experience or internships in a laboratory setting, be sure to highlight these in your responses. Think about the projects you worked on, the methodologies you used, and the impact you made. It's all about telling a story that connects your background to the role you're applying for.
✨Know Their Products
Take some time to familiarise yourself with Piramal Pharma’s product range and recent breakthroughs. Understanding their portfolio not only shows your enthusiasm for the role but also allows you to ask insightful questions that demonstrate your interest in actively contributing to their projects.
✨Be Ready for Regulatory Scenarios
In a full-time pharmaceutical role, understanding the regulatory landscape is crucial. Prepare for situational questions that may test your problem-solving skills concerning compliance and safety standards. You could be asked how you'd handle a hypothetical issue regarding a drug’s market release, so think through your approach.
