GMDP Senior Consultant
Reporting to the Managing Director and working with the EPiC Senior Management team this role offers a high level of hands on client facing consultancy across a range of technical areas, dosage forms and company types.
Key Responsibilities
- Conduct specific client consultancy projects and training assignments appropriate to your areas of expertise, aiming for a target number of client-specific project days of about 150 per annum. (Willingness to travel abroad will be required for some of these)
- Generate reports following each project within a timely manner and in accordance with EPiC procedures.
- Contribute to the EPiC training platform and write and deliver training modules as required.
- Assist with developing and maintaining the EPiC internal Quality System and generate relevant SOPs.
- Prepare presentations and speak at conferences on behalf of EPiC.
Role Requirements
- Education and Experience:
o A bachelor’s degree in a relevant scientific discipline.
o Extensive experience in a quality leadership role within the pharmaceutical industry, with in-depth knowledge of UK and EU medicines regulation and EU GMP requirements.
o Extensive experience of planning, conducting and reporting inspections or audits. An IRCA accredited pharmaceutical auditor is desirable.
o Experience of Sterile product, ATMP and Biological product manufacture is desirable but not essential.
o Eligibility to act as an EU Qualified Person or a UK RPi is desirable. - Skills and Competencies:
o Excellent communication skills (both written and verbal).
o Excellent organizational and project management abilities.
o Analytical thinking and problem-solving skills.
o Proficiency in using office software (e.g., Microsoft Office, project management tools).
o Strong presentation skills - Knowledge:
o In-depth knowledge of UK and EU medicines regulation and EU GMP requirements.
o Understanding of pharmaceutical quality systems and compliance.
o Awareness of ISO certification processes.
o Knowledge of regulatory bodies (e.g., MHRA, EMA) and their requirements. - Personal Attributes:
o Proactive and self-motivated.
o Ability to work independently and as part of a team.
o Attention to detail and commitment to quality.
o Professional and Ethical
o Valid UK driving license.
If you meet the above role requirements and want to be part of a team who have first-hand knowledge of regulatory inspections and compliance and are passionate about making a difference in the pharmaceutical industry, we encourage you to apply!
If you need to arrange a call with one of the EPiC team for further information then please send an email to enquiries@epic-auditors.com titled ‘Recruitment Enquiry’
How to Apply
Please send an email to enquiries@epic-auditors.com titled ‘Application’ containing a copy of your CV and a letter specifying which role you would like to be considered for and outlining how you meet the role requirements.
The closing date for applications is 14th September 2024
Download the job description here;