QA Officer

工作内容

Job Summary:

LM Manufacturing LTD is looking for a Quality Assurance Analyst to join our team.

Responsibilities:

· Ensuring that all GMP activities are performed in accordance with the regulatory and legal requirements and in compliance with the requirements of the current GMP, company SOPs and Health and Safety policies/SOPs.

· Creation, Implementation, Monitoring, Review and Continuous Improvement initiatives of cGMPs, Quality Management Systems (QMS) and procedures as assigned / required by Head of QA.

· To review and issue Master batch documentation (BMR/BPR/GPS) for production activities.

· Review of executed batch records of all stages of manufacturing and packing along with supportive documents. (BMR, BPR, GPS, Protocols, Reports etc.)

· Responsible for assuring that all the requirements of Batch certification and release are fulfilled.

· Preparation of certificate of conformance (CoC) for all products to be certified / released for distribution.

· To prepare, review, update QA SOPs and ensure implementing Standard Operating Procedures at the site.

· Operational execution of Document Control, Training, Customer complaints and Recalls, to maintain compliance with GMP standards.

· To investigate and prepare investigation report and a trend report for market complaint, recall to identify any adverse trends and to suggest an improvement.

· To manage & lead self-inspection activities and to perform self-inspection GMP audits along with cross-functional team.

· Issuance, distribution, archival, retrieval of completed documents.

· To be part in supplier assessment and vendor approval and maintain all the related documents.

· Ensuring good relations and communications with all members of the team and in a timely fashion to internal and external customers.

· Working with all members of staff and management to improve and maintain the positive quality culture within LM Manufacturing Ltd.

· To support the Head of Quality Assurance in ensuring the efficient functioning and implementation of all the Quality Assurance related activities at the site.

· Undertaking any other duties within & for any other department within the business, which may be requested by the Head of Quality Assurance for which training and/or an explanation has been provided and understood.

Essential Skills and Experience:

· Pharmacy/ Science Graduate, or equivalent, with experience of cGMP and working within a Quality management system environment.

· Experience in the Quality Assurance of pharmaceuticals/ medical devices, or a related regulated environment (GxP compliance).

· Demonstrate knowledge and understanding of current GMP and regulatory requirements and guidelines for manufacture licensed medicinal products.

· Knowledge of UK, US and EU quality related pharmaceutical regulations.

· Experience with Document Control, manufacturing activities and IPQA and/ or QMS processes.

· Good interpersonal skills and ability to work well within the organization.

Job Type: Full-time

Salary: £25,000.00-£32,000.00 per year

Benefits:

• Company pension
• Free parking
• On-site parking
• Sick pay

Schedule:

• Day shift
• Monday to Friday

Ability to commute/relocate:

• Northampton: reliably commute or plan to relocate before starting work (required)

Work Location: In person