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Responsible for the day-to-day operational coordination of a varied range of inventory & material management activities at customer facilities. Coordinates activities such as sourcing items or materials and the management and processing of critical materials used in laboratory and production environments, such as consumables, chemicals, solvents and reagents. Coordinates task allocation and streamlines workflows, and contributes operationally to the activities coordinated. Collects, documents, organizes and reports data and observations. Independently solves problems requiring a broad and deep understanding of lab operations and making judgements on the basis of insights gained through experience. Communicates with internal teams and customers on matters that involve a requirement to understand, support and engage others.

Position Profile

In this role, you have the opportunity

• To support a team of QC professionals responsible for routine quality control tasks. Provides technical advice and assistance in specific areas of expertise or ensures quality standards are met for specific products. Ensures adherence to best practice and compliance regulations.

• To provide specific premarketing activities for package inspection, sampling/ re-sampling of incoming materials, (package components, raw materials, bulk drug and excipients).

• To provide premarketing QA data validation on phase-allocated packs against source information, using the GMP (Bill of Materials) BOM Approval Checklist. Additionally, this role provides the post marketing archiving service. To support investigations, reports and compliance inspections.

Tasks

• Complete all aspects of inspection, sampling or testing for certified, part certified or non-certified components and starting materials

• Completion of activities within the specified lead-times in compliance with quality standards

• Complete identification testing on incoming raw material and primary packaging components using validated scientific methods.

  • Complete sampling tasks (samples to be taken in line with sample drawing instructions / resample request).

  • Complete Inspection and testing where specified for package components.

  • Complete the quality assessments and decision for critical package components.

  • Complete the quality decision for certified materials

  • Assess the suitability of temperature data loggers used in transportation of raw and bulk formulated products.

• Complete all the aspects of archiving for Macclesfield Operations on site or via external partners

  • Timely storage, retrieval and disposal of documentation and samples in compliance with the associated quality standards.

  • Receive/store, samples and documents.

  • Record/catalogue information on the archiving database.

  • Retrieve samples and documents when required.

  • Manage the archive space disposing of samples and documents in line with Quality standards.

  • Training and Process Improvement: Plan and deliver RMA (Records Management & Archiving) training to PETs (Process Excellence Teams), fostering a culture of good archiving practices and enhancing overall data integrity across the organisation.

• Complete all aspects of GMP BOM (Bill of Materials) and Pcode Approval

  • Completion of activities within the specified lead-times in compliance with quality standards

  • Data validation on phase-allocated packs against source information (ERV, QDM3, S-Life and Gazelle), using the GMP (Bills of Material) BOM Approval Checklist. Approval of pcodes, control of supply (COS) additions and re-releases.

Responsibilities

• To build strong working relationships and communicate effectively with customers keeping them informed of progress.

• To provide support to compliance and regulatory inspections with direct involvement as appropriate.

• On and update procedures and other related GMP documentation.

• Provide SME input into departmental, site projects and global projects.

• Be competent in systems - EU SAP, GQCLIMS, EWM, EQV (ECMS -complaints, deviations, change controls, audits ERV), QDM3, S-Life, Gazelle, RMA, 1Lab, MODA and CofM databases.

• Respond to requests for data in support of investigations and reports.

• Maintain and enhance own areas of technical competence.

• To manage document updates, deviation investigations, change controls, lab investigations, risk assessments and complaints in compliance with quality standards.

• To participate in local LEAN processes (particularly problem solving) and consistently look for opportunities for continuous improvement.

• Continuing compliance with current Good Manufacturing Practices, Good Distribution Practices, ICH Q10 and customer Policies, Procedures and Practices

All of these activities have a significant impact on the overall success and viability of Macclesfield UKOps and help to ensure availability of products of an appropriate quality to the commercial organisation. This role has an impact on both the financial and reputational aspects of the business.

The ideal candidate's profile

• A scientific degree or proof of multiple years of work-experience in a GMP environment/ GMP archiving preferable in a specialised scientific discipline or regulated environment.

• A comprehensive understanding of how the quality assurance function operates, as well as an understanding of other functions and how they contribute to achieving the objectives of the business within a lean manufacturing environment.

• Good knowledge of IT systems and how to maintain/update data in master templates.

• Ability to make judgements within general operating guidelines.

• An understanding of the QA/QC function, and its role and importance to the business.

• The individual should have a good working knowledge of the industry and be proactive in keeping a track of regulatory changes, new technologies and their impact on the function.

• The individual should have an understanding of Lean processes.

• Good communication skills including cultural awareness.

• Good customer relationship skills.

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Disclaimer:

The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position. Avantor is proud to be an equal opportunity employer.

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