Quality Assurance Officer

Ransom Naturals Limited (RNL) has successfully partnered traditional methods with an innovative approach to new product development since 1846. With a strong ethos to remain a leader in science based natural solutions that improve health and enhance life, the company serves a wide range of international markets and is an important employer in the Hitchin area. Firmly established in the pharmaceutical sector, RNL was the first UK based herbal related pharmaceutical company to receive the GMP (Good Manufacturing Practice) accreditation but also produces a wide range of extracts designed to deliver great taste and functionality to food and drinks.The company was acquired in 2012 by the OBG Group; a privately-owned company based in Liverpool. Today, OBG employs over 300 personnel with a turnover in excess of £80M, generating £10M EBITDA per annum. Job summary To help administer the Quality Management Systems (QMS) at Ransom Naturals Limited. The role holder will conduct batch release, deviations investigations, change controls, root cause analysis, and other quality documents to the requirements of EU GMP, BRC Food Safety Standard and other applicable territories regulations. The role holder will assist in organisation of workload within the QA Department to support the right first-time manufacture, testing, reporting and release of pharmaceuticals and food and beverage products at Ransom Naturals Limited.Key responsibilities and duties ·        Ensure products are fit for purpose before release for use or commercial sale.·        Maintain and improve QMS performance by ensuring items such as deviations, CAPA and change control for which you are the owner are progressed in a compliant and timely manner and all other items are reviewed and/or approved in accordance with internal procedures.·        Support QA team to lead remediation projects·        Will support the maintenance of the site QMS and facilitate reporting of relevant KPIs within department and across site as required.·        Ensure customer or supplier complaints are satisfactorily investigated and communicated.·        Ensure all customer requests and queries are dealt with in a timely manner in line with company procedures.·        Participate in internal and external audits inclusive of customer and regulatory audits.·        Competent to author and approve routine QMS activities.·        Competent to perform Root Cause Analysis using problem solving tools such as Fishbone, 5 Whys etc.·        Authors, reviews, and approves Controlled Documents in accordance with procedures.·        Ensure the coordination of QA workload is appropriate to facilitate right first-time performance and reporting/recording of the manufacturing, testing and release of products at Ransom Naturals Limited.·        Ensure the effective performance of monitoring, reporting and escalation of Quality performance indicators through the QA department to the QA Manager and functional peers/leaders within Ransom Naturals Limited.·        Will support in delivering the site GMP training as required.·        Will conduct the internal audit programme.·        Will support hosting of regulatory and customer audits. ·        Will support in the training and development of QAOs and other staff as required.·        Will provide guidance/advice on Quality considerations within manufacture, testing, reporting and release of pharmaceuticals as required by functional peers across Ransom Naturals Limited.·        Support the materials management process including the qualification of suppliers for raw materials and packaging products and reviewing Technical Agreements.·        Support in the maintenance of Validation activities across all departments.·        Support in the maintenance of HACCP in line with BRC requirements.·        Help conceive, define and deliver Quality related improvements projects.·        Any other activity deemed quality related by the Quality Manager. Behaviour requirements ·        Able to work to high standards with limited supervision. ·        Self-manages most deadlines. ·        Committed to following procedures and adhering.·        to health and safety standards.·        Attention to detail is good and opportunities to improve processes are taken.·        Flexible approach, responding rapidly to changing priorities and deadlines.·        Willing to undertake training as required.·        Takes accountability for identifying correct skills/ people to resolve issues they raise. ·        Capable of considering/proposing solutions that they have not personally experienced before.·        Expect competence making decisions on own work and QA core activities.·        Participates in team discussions and shares perspectives. ·        Seeks advice from manager for new or complex situations. Education and Experience: Bachelor's degree in a science-related field such as chemistry, biology, microbiology, pharmaceutical sciences, chemical engineering, or related disciplinesStrong understanding of Good Manufacturing Practices (GMP) and regulatory guidelinesKnowledge of pharmaceutical manufacturing processes and quality control testingUnderstanding of validation protocols and documentation practicesStrong attention to detail and analytical thinking abilities1-3 years of experience in pharmaceutical, biotechnology, or related regulated industries