To Perform Validation and Re-Validation of Laboratory Equipment Within the Control Laboratory

Post Details
Title of Post: / Quality Control Equipment Validation Specialist
Pay Range: / B
Department/Directorate: / Technical Development, Technical
Accountable to: / Technical Development Manager
Responsible for: / Equipment Validation within the Control Laboratory
Main Job Purpose

To perform validation and re-validation of laboratory equipment within the control laboratory

To prepare user requirement specifications, validation protocols, final reports and any associated documentation required on equipment validation projects

Organisational Structure

Organisation Chart

Key Duties and Responsibilities
Principal Accountabilities:

To carry out validation of new laboratory equipment and the re-validation of existing equipment within the Control laboratory including the writing of risk assessments when necessary.
To plan validation studies and evaluate, assess and report results.
To prepare user requirement specifications, protocols, progress, final reports and any associated documentation on equipment validation projects on an agreed basis. To prepare and implement appropriate project control charts.
To manage the progress of the projects and advise on the most efficient means of attaining the project objectives and project specifications.
To supervise and plan the activity of technical staff involved in the projects.
To participate in relevant working groups relating to the projects.
To train key personnel at BPL in the use of any new equipment.
To assess the European and US Pharmacopoeia updates to ensure that all relevant equipment is maintained in a compliant status.
To co-ordinate the preparation of written specifications, assessment of reply to tender and purchase of new equipment.
To assist in planning and setting up appropriate laboratory facilities.
To liaise with the appropriate personnel on the allocation of resources.
To monitor the laboratory system for the maintenance, calibration and calibration verification of equipment used in the projects.
To ensure the confidentiality and safety of data and intellectual property of a patentable and proprietary nature.
To apply the relevant requirements of Good Manufacturing Practice and Good Laboratory Practice to the projects.
To participate in the BPL systems for internal GMP and Health & Safety audits, and also external supplier audits as required.
To comply with all BPL policies, in particular, the laboratory health and safety instructions, using or wearing the protective equipment and clothing provided.

Principal Resources Controlled:

To be responsible for stock control in area of responsibility and the ordering of laboratory supplies and consumables for project work.
For the careful use, calibration, verification and maintenance of technical equipment instrumentation and computer software packages used in projects.
To be responsible for ensuring the maintenance, service and calibration of allocated equipment/instrumentation and associated records are in compliance at all times for all equipment used in projects.

Planning & Organisation:

To plan own working day and that of any laboratory staff seconded to assist validation projects.
To assist in the maintenance and update of the validation plan for equipment used within the Control Laboratory as appropriate.

To plan, implement, analyse and report evaluations and validations of new or modified equipment.
To write, endorse and authorize, as appropriate, validation plans, protocols, reports and SOPs for the projects. To prepare and implement appropriate project control charts.
To provide and agree annual objectives for the QC Equipment Validation Specialist role with the Technical Development Manager. To then collate and monitor data on routine activities against defined targets and present progress against objectives as required.

Contact With Others:

Liaising with senior management staff at several levels across the site. This will include: BPL Unit and Production Managers (including R+D), BPL Production and Technical Directors, Qualified Persons and Management within the Technical Division.
Technical staff and supervisors within the Control Laboratory regarding day to day operation and maintenance of laboratory equipment.
Representatives of outside organisations and companies regarding equipment within the area of responsibility of the QC Equipment validation Specialist. This might include fault diagnosis, maintenance and upgrades.
Representatives from internal and external auditing functions as part of formal assessment of BPL’s operations and the part the Technical Development function plays in routine manufacturing activities.
Maintain links with other technical specialists through specific user groups or other professional bodies.
To be responsible for the training of other BPL staff at all levels in areas of specialist knowledge such as equipment validation.
Maintaining effective working relationship with specialist groups within BPL such as the Regulatory Affairs and R&D regarding the achievement of common objectives.

Major Challenge of the Job:

To ensure that Control laboratory remains compliant with respect to equipment validation.
To ensure that all equipment validation is adequately planned and that projects are completed in a timely manner.
To ensure that all validation documentation is completed according to company policies and procedures and is managed in a manner that is both secure and readily accessible for audits and inspections.

Knowledge, Skill and Experience Required:

A scientific degree science and/or a minimum of five years relevant pharmaceutical/laboratory experience, preferably in a BPL laboratory.
Experience of equipment validation and an understanding of the principles involved in the validation cycle including DQ, IQ, OQ and PQ.
Experience of planning and project management, including involving the supervision of staff.
An understanding of the regulatory and quality issues affecting both pharmaceutical product manufacture and equipment validation.
An ability to recognize and implement necessary changes to existing procedures in order to modify existing BPL workflow patterns.
Experience of people and resource management.

Decision Making Authority:

Establishment of the most appropriate procedures and strategies for the direction of the QC Equipment Validation Specialist role in order to best maintain compliance and achieve efficiency.
For the writing of procedures, plans and validation documentation.
For ensuring own work is covered in planned absences.

Other Information:

The post holder will be expected to promote and develop both GMP awareness and compliance within their section and where necessary to implement a plan of action in follow up to internal and external audits.
The post holder will be expected to comply with all relevant BPL policies.
The post holder will be expected to operate in an advisory manner, and to offer a service in any areas relating to specialist skills.
To be a member of any relevant working parties.

Acceptance and Review

Accepted

Manager’s Signature: ...... Print Name: …………………...... Date: ......
Jobholder’s Signature: ...... Print Name: ...... Date:......

H:\D05\DATA\PERS\Recruitment\Job Descriptions (JD)\Technical\Technical Development\2015\QC Equipment Validation Specialist JD - Apr 15.doc1