Job Description

PRIMARY RESPONSIBILITIES

· Batch certification as per Directive 2001/83/EC.

SECONDARY RESPONSIBILITIES

· Responsible for the review and approval of Standard Operating Procedures, review and approval of study protocols

· Responsible for CMO management and compliance

· Responsible for being part of internal and external auditing as Lead auditor for GMP, GCP, GDP and GLP purposes;

· Managing Quality Assurance and Working cross functionally with Quality Control Departments for the involvement and overview required to the role in all the Quality System related tasks, with proactive participation in problem solving in case of GMP, GCP and GLP issues.

· Provide input into the Regulatory strategy for the development of pharmaceutical products in the UK

· Liaising with the Regulatory Authority/MHRA contact for all pharma products sold in UK

· Working cross functionally with Pharmacovigilance, Regulatory Affairs, Clinical Research

· Managed in all aspects of the sterile production including design, installation, operational and performance qualifications and process validation.

· Plan, execute and supervise the standard training program for all new employees and maintain continuous training for all staff

· Develop training courses as a separate business unit within the department

· Maintain all professional knowledge databases

· Ad hoc projects

· Any other duties as and when required

Required Knowledge, Skills, and Abilities

· Eligible to be named as a Qualified Person · Preferable Experience in the licensed manufacture of the following: Oral solid dosage Oral liquid dosage · Practical experience of auditing for GMP, GCP, GDP and GLP purposes · Experience of Quality Management Systems