Overview: The Seda group was formed ten years ago and has undergone a rapid growth phase during this time. The group is made up of two divisions, Seda Pharmaceutical Development Services (PDS) and Seda Clinical Manufacturing Services (CMS). Seda PDS is a well-established and highly regarded Contract Research Organisation (CRO) that provides integrated Pharmaceutical Development and Clinical Pharmacology services to enable clients to progress their novel new chemical entities through the drug development process. Seda CMS provides GMP manufacture, testing, and supply of the products we design under contract for our global client base. We aim to offer our clients the very highest level of scientific rigour aligned with expert knowledge of product manufacture and supply. For our colleagues we offer the opportunity of a rewarding career, making a real impact on the development and introduction of life changing medicines, with scope for outstanding personal growth.We are currently recruiting for the role of QA Officer in our Seda CMS division, located at our new, state-of-the-art GMP clinical manufacturing facility in Cheadle, South Manchester. Job purpose: The primary aims of this role, as a key member of the quality assurance function, is to contribute to ensuring that the products manufactured in our facility comply with GMP standards The role will primarily provide support to QC, GMP operations, and Facilities functions through the management of the PQS to strengthen our quality culture. Key responsibilities: Documentation: Ensure effective management of the document lifecycle, ensuring compliance with regulations and industry best practices. This includes:- Creating, reviewing, and approving key documentation such as specifications, SOPs, protocols, and methods associated with a product.- QA review and dossier collation of GMP production and analytical documentation prior to QP release. Quality Systems: Good understanding of QMS, ensure compliance with SOPs and regulatory standards. This covers:- Investigating and addressing deviations to prevent future occurrences.- Managing supplier suitability and mitigation steps for supplier complaints raised.- Assessing changes and their impact on the site through Change Control- Evaluating site compliance and implementing improvements through internal audits- Proactively identify and manage site improvements for Quality Improvement through CAPAs.- Trained and competent in internal auditing is desirable but not essential.- Provide methodical input in problem-solving activities, such as investigations into deviations or product complaints, ensuring root causes are identified and mitigated.- Ensure that suppliers and third-party vendors meet quality standards. Manage supplier quality agreements and conduct periodic reviews of their performance. Support: Provide support to other business functions and within QA. This includes maintaining good client relations, liaising with contractors, and supporting the wider Seda team to ensure satisfactory project completion. Training: Ensure training on procedures (SOPs) is up-to-date and in line with industry standards. Prepare and conduct quality training sessions, including induction and GMP training. About you: You'll be educated to degree Level in a relevant scientific discipline and we're looking for someone with a minimum of 2 years' of experience in a QA role within a Pharmaceutical (GMP) facility, preferably Investigational Medicinal Products (IMPs).You will have excellent communication skills, both written and spoken English and have a good level of attention to detail and ability to work to the highest quality standard.At Seda, we have a culture of development and collaboration, and we expect all of our team to have a self-development mindset coupled with the ability to work well in a team. Additionally, you will have the ability to prioritise and meet different deadlines in alignment with business needs.Job Types: Full-time, PermanentPay: £28,000.00-£35,000.00 per yearBenefits: Company pension Free parking Life insurance On-site parking Private medical insuranceApplication question(s): How many years experience do you have of working in a GMP environment?Work Location: In personApplication deadline: 18/08
