Site Name: UK – Hertfordshire – Ware RD
Posted Date: Sep 14 2020
To be the person to ensure all operations relating to the Ware Pilot Plant facility and equipment are fully compliant with Quality and EHS regulatory expectations. This will be delivered through focusing on both tactical and strategic deliverables, working with stakeholders (Quality, EHS and business partners) Subject Matter Experts, suppliers and consultants to efficiently deliver a range of associated activities and agreed levels of compliance, culture and other tangible benefits.
– Initiates and leads the implementation of improvements in regulatory compliance
– Continually review ways of working for compliance to established procedures, policies and regulations
– Compile compliance metrics and based on analysis of deviation trends, data from Management Monitoring, Concerns and/or Risk logs, Operational Occurrence reporting and /or observations from staff.
– Identify gaps in current ways of working, controlled documents, accepted practices etc and lead initiatives to address these gaps.
– Serve as point person to support department, divisional, and/or corporate compliance initiatives
– Participate in continuous improvement initiatives providing a point of view from a compliance perspective
– Establish and enhance relationships with Quality and EHS organisations to grow the compliance culture in Ware Pilot Plant
– Utilises compliance knowledge to provide critical input to the design and continuous improvement of Ware Pilot Plant process and to ensure standards are maintained
– Provide support to the Management Monitoring programme and maintains oversight
– Lead compliance culture improvement initiatives in Ware Pilot Plant operations
– Lead and/or support Quality/EHS investigations as appropriate
– Facilitate root cause analysis exercises
– Provide objective review of investigations
– Work with Quality and EHS organisations to ensure compliance with expectations
– Acts as a key contact for Ware Pilot Plant personnel with respect to process improvements and compliance activities
– Ensures all business processes in Ware Pilot Plant are robust, repeatable and consistently employed and compliant with the associated regulations. Proposes and drive changes to business processes where required in order to meet this expectation
– Act as key business contact for the readiness, management of and follow up to all external and internal audits and inspections
– Oversees the on-time delivery of key annual compliance trend reports e.g., Environmental Monitoring, Area and Line Clearance and Purified Water system
– Act as concerns and risk champion for Ware Pilot Plant
– Act as Business Continuity lead or Ware Pilot Plant
– Keeps a breast of regulatory expectations relating to Ware Pilot Plant operations
– To own and execute a portfolio of “projects” focussed on delivering more compliant operations
CLOSING DATE for applications: 25th September 2020
Please take a copy of the Job Description, as this will not be available post closure of the advert.
When applying for this role, please use the ‘cover letter’ of the online application or your CV to describe how you meet the competencies for this role, as outlined in the job requirements above. The information that you have provided in your cover letter and CV will be used to assess your application.
– Relevant graduate science/engineering qualification
– Previous experience working in a pharmaceutical manufacturing environment
– Extensive knowledge of the site QMS and Regulatory Requirements (Safety and Quality) relative to the defined business process
– Experience in change management methodology
– Exceptional influencing, leadership and decision-making capabilities
– Knowledge of historical, current and anticipated Compliance expectations
– Sufficient scientific/processing credibility to effectively interface with and influence key stakeholders, internal and external
If you have the following characteristics, it would be a plus:
– Broader knowledge of professional environment, associated disciplines, and commercial awareness.
– Demonstrated project management competency/expertise.
– Understanding of operational excellence and leadership principles
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