Scientific Compliance Manager

5 days left

£0 per annum
28 Jul 2017
25 Aug 2017
William Blohm
Contract Type
Full Time
Job Purpose:
- Managing programs & projects to deliver significant improvements in QC and product sciences capabilities, efficiency, throughput and compliance.
- To lead, organise and manage required Laboratory functions such as equipment, compliance investigation and personnel issues within the team including performance management, absence management and development.
- To ensure all work is to appropriate regulated standards

Generic Responsibilities:
- To comply with all GMP regulations as instructed by management, the Quality department, or as per the Orange Guide
- To carry out all duties whilst maintaining good Health & Safety practice with due care to yourself and others
- To control and maintain your personal training folder
- To comply with all Company policies and procedures
- To carry out any other reasonable request as directed by your Manager or another member of the Management team
- To follow a code of conduct conducive to a professional environment

Key Responsibilities:
- The role is responsible for managing programs & projects to deliver significant improvements in QC and product sciences with focus on compliance, capabilities, efficiency and throughput
- This will be achieved through line management of LIMS functions with clear & simple project management
- The role has multiple responsibilities, expanded below:

- Organise and prioritise workloads and assignments of staff in conjunction QC & Method Development and Production requirements including objective collation, management, tracking and delivery
- Ensuring the effective operation of the laboratory to budget including management of consumable budgets
- Analytical method development/validation tracker maintenance, status updates & prioritisation
- Develop programs to improve laboratory efficiency and reduce costs.
- Prospective CAPEX, equipment review consideration for depreciation

- To drive positive, rational & compliant change in departments, in adjacent science teams and across the business
- Management and support the delivery of compliance activities including NC/CAPA, change control, PD and HS&E
- Support investigation of atypical results and quality system failures related to assay performance and action accordingly
- Act as a host and/or participate in audits/inspections by customers, internal auditors and external regulatory bodies
- To perform self-inspections & effectively co-ordinate improvements
- To ensure matching/appropriate standards of GMP are adhered to ensure matching quality between science departments

Change Management
- Drive efficient through change control and CAPA
- Efficient link of QC, MD, RA and QA systems for efficient change
- Provide QC, MD & Stability data in support of License variation

Representative Roles
- IMP test representative; coordinate IMP testing (IP, release and stability) and supply of data including appropriate review of specification
- Joint HS&E representative for QC & Development
- CAPEX accountability across laboratories including software
- Provide Head of QC & Method Development with metrics representing assay, product & team performance
- Deputise for Head of QC & Method Development as appropriate
- To provide cover for other QC & Method Development Leaders/Managers as and when required

Line Management
- To ensure teamwork is promoted and individual skills are utilised
- To manage all personnel issues in line with Company policies and to ensure an effective and efficient team environment, obtaining advice/support from the Head of QC & Method Development and/or HR as required
- To carry out disciplinary investigations and/or actions in line with Company policies
- To use appropriate methods and a flexible interpersonal style to help build a cohesive team; facilitating the completion of team goals
- To effectively manage the Performance Review and Performance Agreement process with all team members through regular feedback meetings
- To manage team absence in accordance with the Company Absence Procedure
- To ensure all compliance with all Company policies and procedures
- To ensure training of Scientists & teams is in line with Company requirements

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