Job Description

KEY ROLES/RESPONSIBILITIES:-

Departmental Operations:

Establish day-to-day priorities and perform assigned work as agreed with the Bio-Assay Management. Ensure efficient use of time to complete the assigned objectives. Act as in-house expert for bio-analytical methods. Lead and support projects to deliver method development, qualification and validation studies, routine QC release and stability data for biological assays according to defined SOPs and protocols. In compliance with best cGMP working practices and techniques, ensuring the data and reports are suitable for regulatory filings. Maintain laboratory areas, ensuring procedures are complied with to meet client, regulatory GMP and safety requirements. Be accountable for the bioassay laboratories being clean, tidy and well-organised and in a state of continuous inspection readiness. Execute calibration of equipment and instruments, informing relevant personnel in a timely manner of any failure of calibration. Carry out general maintenance and housekeeping of equipment. Ensure that at any time equipment, facilities and materials used in the area of responsibility comply with defined standards. Provide training and troubleshooting support to Development and Quality Control groups as required. Check and review data in compliance with Data Integrity requirements. Engage in and lead specified compliance and improvement projects, as necessary. Ensure economic use of labour, materials, energy and services, proposing and implementing measures for cost reduction and waste minimisation to meet the department and site targets. Contribute to the management of the laboratory ensuring effective systems are in place to meet client, regulatory GMP and safety requirements. Identify opportunities for improved methods of working to enhance efficiency, cost control and safety/GMP performance. Support and provide training of new members of staff. Assist Bio-Assay team in the implementation and tracking of measures and targets:
1)Release, Stability, Development, technical transfer and validation


2)Troubleshooting


3)Deviation, change control and commitment tracking close out


Assist in the introduction of new equipment by supporting IQ/OQ/PQ and comparison studies where applicable Be the system owners of Bio-Assay equipment, assisting in equipment periodic reviews, monitoring and maintaining calibration status of equipment within the Bio-Assay department.

Project Delivery:

Responsible planning workload to ensure that assigned projects and deliverables are fully completed on time. Lead projects and teams as necessary and in agreement with Bio-Assay Management. Lead development, technical transfer, qualification, validation activities and technical support for bio-analytical methods. Plan and carry out work, as agreed with Bio-Assay Management, to ensure effective project progression in line with customer requirements. Liaise with client technical groups and where necessary provide advice and direction on biological assay requirements. Responsible for the QC release testing, stability testing, method development, qualification/validation, technical transfer and troubleshooting related to biological assay test methods. Take decisions on scheduling of routine testing including release and stability, development, technical transfer and validation in conjunction with other technical staff to ensure required timelines are met. Provide cover for other Bio-assay team members as required. Client communication as required, in a professional manner.

Quality:

Have ownership and ensure timely close out of deviations, investigations, change controls and commitment tracking. Immediately escalate any OOS results or deviations to materials, facilities, processes or procedures to bio-assay and QC management. Apply best cGMP work-practices and techniques to manage the testing and release bulk drug substance, final products and stability products within specification and in accordance with Data Integrity requirements, Annex 11 Computerised Systems and 21CFRpart11 Good Documentation Practices for Electronic Data Uphold cGMP principles and ESH standards, continually seek opportunities to improve and enhance standards, and encourage other staff to do likewise. Record all laboratory work in standard official notebooks or analysis sheets as appropriate, and compile results and observations for incorporation into technical reports. Adhere to the relevant procedures. Follow all appropriate protocols and procedures as required for the work undertaken. Ensure accuracy of raw data and analytical interpretations Write and update of SOPs, instructions and protocols and other documentation * Actively contribute to department and site audit readiness requirements including any continuous improvement initiatives.

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