Achieva Group Ltd

Quality Specialist

Location
Hertfordshire
Salary
Not specified
Posted
14 Apr 2021
Closes
14 May 2021
Ref
BH-25598
Contact
Sophie Fosh
Discipline
Clinical Research
Hours
Full Time
Contract Type
Contract
Experience Level
Experienced (non-manager)
Our global pharmaceutical client has a vacancy for a Quality Specialist.
 
Our client is looking for candidates based in the UK.
 
This is an initial 20-month full time contract.
 
Job Purpose:
· Implement the controlled document strategy for all relevant regulatory compliance standards and processes related to clinical development and safety/pharmacovigilance.
· To develop Global Procedural Documents, e.g., Policies, Standard Operating Procedures (SOPs), Work Instructions (WIs) from identification of needs to execution of development and deployment of outputs and materials.
 
Primary Responsibilities and Accountabilities:
· Supports establishment of GxP Global Procedural Documents throughout all development related organizational enterprises to ensure a consistent GxP process landscape for standards and processes and procedures related to clinical development and safety/pharmacovigilance which meet internal and external standards of regulatory compliance, as well as industry best practices and interpretations.
· Builds and maintains strong relationships with key business stakeholders and ensures that the providing of an efficient, effective and compliant process landscape to the functions.
· In close collaboration with supported functional areas and key business stakeholders, identifies needs for process standardization, regulatory compliance direction and areas for improvement.
 
Experience, Skills, Knowledge:
· Experience developing multiple Procedural Documents simultaneously to high quality.
· In-depth knowledge of pharmaceutical development processes, including Quality Management Systems, and relevant GxP regulations.
· Strong interpersonal and stakeholder management skills, including a customer focused approach, and highly effective teamwork and collaboration.
 
Education/Qualifications:
· Bachelor’s degree or equivalent in scientific or quality-related field or equivalent combination of education, training, and experience.
· 3-5 years in the pharmaceutical industry, preferably in pharmaceutical development and working in a GxP regulated area.
· Experience in preparation, development and administration of GxP standards and processes.
· Organizational awareness (e.g., interrelationship of departments, business priorities), including experience successfully working cross-functionally and in global teams.
 
Minimum:
· Demonstrated knowledge of GCP and/or GVP regulatory requirements, as well as analytical, organizational and planning skills.
· Broad understanding of global expectations of Regulatory Authorities in the area of pharmaceutical development.
 

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