Principle Quality Assurance Officer

Ransom Naturals Ltd; Hitchin; On-site; GBP 30,000 - 40,000; Full time

Job summary

A leading company in pharmaceutical manufacturing is seeking an entry-level Quality Assurance Officer to administer Quality Management Systems (QMS). The role involves conducting batch releases, investigations, and ensuring compliance with regulations. Ideal candidates should have strong problem-solving skills and attention to detail, with a commitment to high standards and flexibility in a fast-paced environment.

Qualifications

• Competent to perform Root Cause Analysis using tools like Fishbone, 5 Whys.
• Will support in delivering site GMP training.

Responsibilities

• Ensure products are fit for purpose before release.
• Maintain and improve QMS performance.
• Support QA manager with Quality trainings.

Skills

Attention to Detail

Problem Solving

Flexibility

Job description

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 manager to lead remediation projects
• Support QA manager with Quality trainings.
• 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 and/or host 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.
• 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.

Seniority level

• Seniority level

  Entry level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Quality Assurance

• Industries

  Pharmaceutical Manufacturing

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