Mundipharma Research Ltd
Job Description
JOB TITLE:
Senior Scientist
Pharmaceutical Operations
Grade 1 and Grade 2
SECTION:
DEPARTMENT:
Technical Support
COMPANY: Mundipharma Research Ltd
RESPONSIBLE TO: Head of Technical Support
A.
DATE:
Pharmaceutical Operations
June 2013
BROAD PURPOSE OF JOB
To support the activities of the Technical Development (TD) Directorate by managing the
procurement, receipt storage, dispensing, issue, dispatch, return and destruction of materials and
products used in formulation and process development of a range of pharmaceutical products by
Pharmaceutical Development.
To support the activities of the TD Directorate by managing the receipt, storage, dispensing, issue,
dispatch of bulk materials and destruction of materials and products used by the Clinical Supplies
Department for Clinical Studies.
To support the activities of the TD Directorate by managing, the equipment and facilities used in
formulation, process development and clinical trial supplies.
B.
SPECIFIC DUTIES AND RESPONSIBILITIES
1.
Manage the procurement, approval, control, storage and dispensing of materials to support
the pharmaceutical development projects within the appropriate timelines.
2.
Manage the receipt, approval, control (in conjunction with Clinical Supplies), storage and
dispensing of materials to support Clinical Supplies studies within the appropriate timelines.
3.
Co-ordinate the supply of materials for required project work/Clinical Studies and ensure
progress and timelines are communicated appropriately to the relevant group. Maintain,
review and continually develop an effective stock control system. Manage the retention
samples including regular inspection. Ensure all procedures are documented and adhered
to. Provide scientific and regulatory guidance in the management of stock control and
dispensing of materials. Provide innovative solutions and encourage other team members
to do the same.
4.
Take receipt of returned Clinical Supplies and store appropriately. Manage the destruction
of expired and un-required stock for Pharmaceutical Development and as requested for the
Clinical Supplies Department.
5.
Undertake or assist with the dispatch of materials and products as appropriate by the
requesting department. Ensuring shipments are packed, stored, labeled and dispatched
under appropriate conditions with supporting documentation available.
6.
Develop contacts and establish working relationships with external suppliers to ensure all
Pharmaceutical Development materials sourced are of the required quality and are
provided in an efficient and timely manner.
7.
Work with the appropriate personnel from Pharmaceutical Development and Clinical
Supplies in order to plan and ensure continuity of the supply of materials for specified
projects and studies.
8.
Ensure the maintenance, cleanliness and validation status of laboratory equipment and
facilities for Pharmaceutical Development and Clinical Supplies groups are appropriate for
the work to be undertaken and in accordance with the Good Manufacturing Practice (GMP),
Good Laboratory Practice (GLP) and Standard Operating Procedures (SOPs).
9.
Provide supervision and guidance to other team members to ensure that scheduled
cleaning and maintenance of equipment is done at the appropriate time. Ensure resources
are available as and when required to maintain continuity, compliance and efficiency in the
manufacturing activities within the Pharmaceutical Development and Clinical Supplies
manufacturing areas.
10.
Take responsibility for personal training and development in order to reach and maintain the
required level of skills, knowledge and experience to perform the role. Maintain accurate
training records. Proactively participate in the company Performance Assessment System,
including the agreement of objectives which meet the business requirements and enable
personal development and progression.
11.
Assist in the recruitment and selection process for new employees within Pharmaceutical
Operations as requested by the Head of Department.
12.
Assist in budgeting for capital equipment and resources by providing practical and scientific
recommendations.
13.
Conduct, organise and recommend the training for other team members, in order to
maintain and develop the effectiveness of the Department. Ensure individual training
records are completed.
14.
Ensure all work is undertaken in compliance with the requirements of cGxP (Current Good
‘Clinical, Laboratory, Manufacturing, Pharmaceutical’ Practice), relevant codes of practice
(e.g. Medicines Act 1968, EU Directives) and company/departmental SOPs. Ensure
compliance with the requirements of Control of Substances Hazardous to Health (COSHH)
and Health and Safety at Work Act 1974 (HASAWA).
15.
Undertake any other reasonable tasks, to help fulfil the objectives of the Department.
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Mundipharma Research Ltd