Download JD_GDP_Compliance_Senior_Executive

JOB DESCRIPTION
Job Title:
GDP Compliance Senior Executive
Department:
Quality (London)
Reports to:
Quality Compliance Manager & RP
Number of Reports: Nil
MAIN PURPOSE OF ROLE:
To ensure the organization abides by the guidelines on Good Distribution Practice (GDP)
according to the Quality Management System (QMS) in place, in line with the EU Guidelines
on Good Distribution Practice Medicinal Products for Human Use (2013/C 343/01).
KEY RESPONSIBILITIES:
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All distribution activities are inline with the relevant process licenses held within the
organisation
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Direct communication with all third party distributors
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Lead the investigation and closure of deviations related to GDP activities e.g.
Temperature excursion deviations
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Management and maintenance of system for bona fide checks for direct
customers and third party distributors
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Effective communication with the Quality and cross functional teams
KEY ACCOUNTABILITIES:
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To document and verify the global transportation routes taken for all AMCo products,
working closely with the Supply Chain department and external contractors.
To assess the temperature monitoring / control requirements for each transportation
route.
Periodic review of validated transport routes to ensure compliance and adherence.
Build and maintain a strong and co-operative relationship with the competent
authorities enhancing AMCo's reputation over time
To assist in ensuring that an effective QMS is implemented and maintained
To assist in the maintenance of AMCo Wholesalers Dealers Authorisation and
Controlled drugs licenses.
To coordinate the supply of Controlled Drugs inventory information to the Home
Office.
To assist in the coordination and execution of any recall operations of medicinal
product in accordance with AMCo procedures.
To ensure that GDP relevant customer complaints are dealt with effectively in
accordance with AMCo procedures
To ensure that adequate and complete records relating to GDP are maintained
To approve and deliver the initial and continuous training program in relation to GDP
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To ensure that all personnel are trained to carry out their respective duties in relation
to GDP
.To oversee self inspection of the relevant areas of the QMS.
To ensure contracts are in place between AMCo and Contract Acceptors relating to
distribution activities.
To employ due diligence in the discharge of duties and to report to senior
management and the relevant EU authority of any awareness of suspicious events or
falsified products.
To be present during an inspection by the competent authorities
To keep up to date with current regulations and industry standards through a program
of continuous professional development.
GDP Compliance Senior Executive
Requirement
Essential
Desirable
Qualifications:
B.Sc
Science Graduate (Chemistry / Biology /
Pharmacy (or close equivalent)
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M.Sc
Experience & Competences
Minimum 2 years’ experience of working in a
similar role within a pharmaceutical company
Candidate should have sound working
knowledge of all GDP relevant regulations
Experience in controlling and directing the
wholesale distribution of medicinal products
Registered with the MHRA as Responsible
Person on a Wholesalers dealers authorisation
Experience of working in a virtual company
environment
Knowledge & Skills
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Knowledge of GDP / QMS
Good communication skills
Investigational skills
Decision making & problem solving skills
MS office
Trackwise
Personal Qualities
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A Methodical, Hardworking individual
Specific awareness of Company’s culture and objectives
Ability to adapt to change
Proactive
Ability to adapt to change
Date 14.01.2016
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