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Scientific Compliance Manager

West Sussex   •  Competitive  •  Permanent, 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

Compliance
• 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


You must be eligible to work in the UK. Learn more

  • Agency: Hyper Recruitment Solutions
  • Posted: 28th July 2017
  • Expires: 25th August 2017
  • Reference: J4207
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Contact

  • Recruiter: William Blohm
  • Phone: 0203 225 5120
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