Back to Job SearchROLE OVERVIEW
We are currently looking for a Microbiology SME – EU GMP Annex 1 Compliance to join a leading pharmaceutical company on a fixed-term contract. This is a fantastic opportunity for an experienced microbiology professional with a strong focus on compliance and sterile manufacturing. The role is based 100% onsite, offering a pivotal position to lead documentation reviews, remediation strategies, and ensure adherence to the latest EU GMP Annex 1 standards.
As a key member of the team, you will play a critical role in supporting compliance activities, working closely with QA, Microbiology, Validation, and Manufacturing teams to maintain high standards across sterile manufacturing processes.
KEY DUTIES AND RESPONSIBILITIES
Your duties as the Microbiology SME – EU GMP Annex 1 Compliance will be varied; however, the key duties and responsibilities are as follows:
- Review completed gap assessments and develop strategic documents aligned with EU GMP Annex 1 requirements.
- Draft comprehensive technical reports that document findings, risk assessments, and remediation plans.
- Prepare written justifications for identified gaps where applicable.
- Define validation and qualification activities needed to address compliance deficiencies.
- As the Microbiology SME you will support inspection preparations and provide expert insights during audits and mock inspections.
ROLE REQUIREMENTS
To be successful in your application to this exciting role as the Microbiology SME – EU GMP Annex 1 Compliance, we are looking to identify the following on your profile and past history:
- A Degree or higher level in Microbiology, Pharmaceutical Sciences, or a related field.
- Extensive industry experience in sterile manufacturing or aseptic processing environments.
- Proven experience with EU GMP Annex 1 2022 revision and writing regulatory-facing technical reports.
WHAT’S IN IT FOR YOU?
This role offers the chance to significantly influence the compliance infrastructure of a leading pharmaceutical organization. You will work in a collaborative environment, providing SME input during inspections and ensuring documentation is submission-ready. It's an excellent opportunity to apply your expertise in a role that directly impacts quality and regulatory success.
Key Words: Microbiology / EU GMP Annex 1 / Compliance / Sterile Manufacturing / Aseptic Processing / Environmental Monitoring / Contamination Control / Validation / Regulatory Inspections / Technical Reports
"Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer. We welcome applications from anyone who meets the role requirements. HRS exclusively supports the STEM sectors, combining recruitment expertise with scientific knowledge to help you advance your career."
Hyper Recruitment Solutions Ltd (HRS) is an Equal Opportunities employer. We welcome applications from anyone who meets the role requirements. HRS exclusively supports the STEM sectors, combining recruitment expertise with scientific knowledge to help you advance your career.
