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Qualified Person
- Port Talbot, West Glamorgan
- £55,000 per annum
- 6 applications
- Job type: Permanent, full-time
- Date:
- Reference: 21175012
Organisation Description
Reed Scientific are recruiting a Site Qualified Person reporting to the Quality Director working within Manufacturing and Supply (M&S) to ensure the effective management of pertinent Quality activities, the achievement of compliance standards both locally and globally, and to develop and maintain quality systems.
Main Purpose
Responsible for implementing QMS on site in support of overall Manufacturing & Supply (M&S) strategic plan.
To help manage and support key sections of the Quality group in line with other job holders. This role engages with all Quality sections and may have personnel responsibilities going forward.
Supporting the Quality Director in working with the Site Operations, Medical, Commercial Business Units and Research & Development to support global quality processes.
Key Result Areas
Quality Standards
Supporting the development and implementation of the QMS on site and globally.
To help manage the operations of relevant Quality functions on site and to ensure that products and clinical trials materials meet the company’s and legal quality standards.
Authorisation of the release of products for sale and clinical trials, make recommendations in instances of non-conformance for disposition and assess their significance in relation to the QMS.
Ensure that process and analysis changes are carried out in an efficient, cost effective and up to date manner, leading to successful conclusion of approved projects.
Deliver on site and global key projects within M&S including Operational initiatives.
Supporting the activities of the Quality Assurance Manager as defined under Quality Responsibilities.
Job Description
Management and Leadership
This role may have line management responsibilities at a later date
Providing direction within Quality aligned with M&S objectives and overall business strategy as applicable.
Supporting the interfaces with Medical, Commercial Business Units, Regulatory and R&D, Global Quality to support global quality processes.
Promote organisational development, establishing a flexible and sustainable organisation.
Staff development, undertaking performance management; (appraisals, evaluations, development and training of staff, including writing and updating job descriptions) as appropriate.
Key talent identification and succession planning of staff within and for M&S roles working with line managers within M&S and other Business Units.
Awareness of and adherence to Health and Safety.
Representative of the company to external bodies and customers.
Control and reporting of costs and expenses.
Support revenue budget of Quality and signing of expenditure as permitted.
Accountability
Support the development and implementation of the Quality Management System on site and globally.
Accountable for designated aspects of Site Quality, ensuring that all manufactured products meet approved Quality standards at time of release and throughout shelf life.
Quality Relationships
Batch Release.
Support management and leadership of the Quality Technical section.
To develop and where necessary establish, communicate and implement Quality procedures to ensure that manufactured products meet approved Quality standards at time of release and throughout shelf life.
Authorisation of specifications, methodology, procedures and documentation which have impact on products and quality.
Compliance
Ensure that internal audits as required by the QMS are scheduled and carried out with the assessment of corrective actions identified.
Site responsibility for ensuring that external audits of material suppliers and suppliers of contract services (manufacturing, packing and analytical) are scheduled and carried out.
Authorisation of addition and deletions from the site’s approved supplier list of materials and contract services.
Promotion and improvement of Quality systems in line with cGMP.
Maintenance and monitoring of keys Quality data including Quality.
Person Specification
Qualifications
A relevant scientific degree is essential and a higher degree is desirable.
Eligible for Qualified Person status under the permanent provision of current EU legislation is preferable. Experience of licensed and/or clinical trials products required.
A proven track record in Pharmaceutical Quality management.
Reed Specialist Recruitment Limited is an employment agency and employment business
Reed Scientific are recruiting a Site Qualified Person reporting to the Quality Director working within Manufacturing and Supply (M&S) to ensure the effective management of pertinent Quality activities, the achievement of compliance standards both locally and globally, and to develop and maintain quality systems.
Main Purpose
Responsible for implementing QMS on site in support of overall Manufacturing & Supply (M&S) strategic plan.
To help manage and support key sections of the Quality group in line with other job holders. This role engages with all Quality sections and may have personnel responsibilities going forward.
Supporting the Quality Director in working with the Site Operations, Medical, Commercial Business Units and Research & Development to support global quality processes.
Key Result Areas
Quality Standards
Supporting the development and implementation of the QMS on site and globally.
To help manage the operations of relevant Quality functions on site and to ensure that products and clinical trials materials meet the company’s and legal quality standards.
Authorisation of the release of products for sale and clinical trials, make recommendations in instances of non-conformance for disposition and assess their significance in relation to the QMS.
Ensure that process and analysis changes are carried out in an efficient, cost effective and up to date manner, leading to successful conclusion of approved projects.
Deliver on site and global key projects within M&S including Operational initiatives.
Supporting the activities of the Quality Assurance Manager as defined under Quality Responsibilities.
Job Description
Management and Leadership
This role may have line management responsibilities at a later date
Providing direction within Quality aligned with M&S objectives and overall business strategy as applicable.
Supporting the interfaces with Medical, Commercial Business Units, Regulatory and R&D, Global Quality to support global quality processes.
Promote organisational development, establishing a flexible and sustainable organisation.
Staff development, undertaking performance management; (appraisals, evaluations, development and training of staff, including writing and updating job descriptions) as appropriate.
Key talent identification and succession planning of staff within and for M&S roles working with line managers within M&S and other Business Units.
Awareness of and adherence to Health and Safety.
Representative of the company to external bodies and customers.
Control and reporting of costs and expenses.
Support revenue budget of Quality and signing of expenditure as permitted.
Accountability
Support the development and implementation of the Quality Management System on site and globally.
Accountable for designated aspects of Site Quality, ensuring that all manufactured products meet approved Quality standards at time of release and throughout shelf life.
Quality Relationships
Batch Release.
Support management and leadership of the Quality Technical section.
To develop and where necessary establish, communicate and implement Quality procedures to ensure that manufactured products meet approved Quality standards at time of release and throughout shelf life.
Authorisation of specifications, methodology, procedures and documentation which have impact on products and quality.
Compliance
Ensure that internal audits as required by the QMS are scheduled and carried out with the assessment of corrective actions identified.
Site responsibility for ensuring that external audits of material suppliers and suppliers of contract services (manufacturing, packing and analytical) are scheduled and carried out.
Authorisation of addition and deletions from the site’s approved supplier list of materials and contract services.
Promotion and improvement of Quality systems in line with cGMP.
Maintenance and monitoring of keys Quality data including Quality.
Person Specification
Qualifications
A relevant scientific degree is essential and a higher degree is desirable.
Eligible for Qualified Person status under the permanent provision of current EU legislation is preferable. Experience of licensed and/or clinical trials products required.
A proven track record in Pharmaceutical Quality management.
Reed Specialist Recruitment Limited is an employment agency and employment business
