Job Title:                     Associate Director (Deputy QP) - UK

Industry:                      Pharmaceuticals/Biotechnology/Clinical Research

Location:                    United Kingdom

Salary:                         Competitive Salary Package + Benefits

Job Description:

Educational qualifications:

A licensed pharmacist with 10-12 years of experience

Relevant experience:

• Must have experience of working in larger pharmaceutical companies in manufacturing and quality setups
• Must be certified, trained and acquainted with regulation related to EU Pharmaceutical

Accountability Cluster

• To ensure that each batch of product has been manufactured in compliance
• To ensure that each batch imported to the community has undergone overall specifications as described in the guidelines
• To ensure that the Registers or equivalent document are kept up to date as operations are carried out.
• To ensure overall Quality system of the company in compliance with regulations and company legal framework

3. Key Accountability

Accountability Cluster & Major Activities / Tasks

• To ensure that each batch of product has been manufactured in compliance. Requirements specified as per the national laws of the country or EU

Requirements of Marketing authorization

• To ensure that each batch imported to the community has undergone overall specifications as described in the guidelines. To ensure complete quantitative and qualitative analysis of products imported from outside the EU in accordance with the requirements of the Marketing Authorization Quantitative

The necessary release certificates are completed and issued as per EU guidelines

Ensure necessary amount of reference samples are stored for each batch of products that is released and distributed

The manufacturing and quality control testing processes have been validated

• To ensure that the Registers or equivalent document are kept up to date as operations are carried out. Provide certifications in register or equivalent for product release or sale in EU market

Maintain records such as Quality Management Review, Annual Product Review reports, relevant deviations, CAPA’s, Risk Assessments, change controls, Self-Inspections etc.

The necessary Quality agreements are in place with third parties who are performing GMP related activities

• To ensure an overall quality system of the company in compliance with regulations and the company legal framework. Laisse and serves as single point of contact for quality and compliance questions, issues and product recalls

Ensure all applicable Corporate Quality and Compliance Policies, procedures and requirements are implemented and specific local requirements are met. Plan, drive and track all affected employees for necessary guidelines/SOP trainings and verifying efficiency from time to time