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Are you a seasoned Microbiology SME with a passion for compliance and sterile manufacturing? Our client, a leading company in the pharmaceutical industry, is seeking a Microbiology SME – EU GMP Annex 1 Compliance to join their team on a fixed-term contract. This role is based 100% onsite and offers a unique chance to lead documentation and remediation activities to support compliance with EU GMP Annex 1 for sterile manufacturing.
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:
1. Review completed gap assessment and Annex 1 strategy documents.
2. Draft comprehensive technical reports documenting findings, risk assessments, and remediation plans.
3. Prepare written justifications for identified gaps where applicable.
4. Define required validation and qualification activities to address compliance deficiencies.
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:
1. Advanced degree in Microbiology, Pharmaceutical Sciences, or a related field.
2. Extensive industry experience in sterile manufacturing or aseptic processing environments.
3. Proven experience with EU GMP Annex 1 2022 revision and writing regulatory-facing technical reports.
This role offers the chance to make a significant impact on the compliance and quality standards of a leading pharmaceutical company. You will collaborate closely with QA, Microbiology, Validation, and Manufacturing teams, providing SME input during inspections or mock audits. Your expertise will ensure that all documentation aligns with the latest EU GMP Annex 1 2022 revision expectations, making it submission-ready for regulatory agencies.
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 Life Science sectors, combining recruitment expertise with scientific knowledge to help you advance your career.
Are you a seasoned Microbiology SME with a passion for compliance and sterile manufacturing? Our client, a leading company in the pharmaceutical industry, is seeking a Microbiology SME – EU GMP Annex 1 Compliance to join their team on a fixed-term contract. This role is based 100% onsite and offers a unique chance to lead documentation and remediation activities to support compliance with EU GMP Annex 1 for sterile manufacturing.
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:
1. Review completed gap assessment and Annex 1 strategy documents.
2. Draft comprehensive technical reports documenting findings, risk assessments, and remediation plans.
3. Prepare written justifications for identified gaps where applicable.
4. Define required validation and qualification activities to address compliance deficiencies.
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:
1. Advanced degree in Microbiology, Pharmaceutical Sciences, or a related field.
2. Extensive industry experience in sterile manufacturing or aseptic processing environments.
3. Proven experience with EU GMP Annex 1 2022 revision and writing regulatory-facing technical reports.
This role offers the chance to make a significant impact on the compliance and quality standards of a leading pharmaceutical company. You will collaborate closely with QA, Microbiology, Validation, and Manufacturing teams, providing SME input during inspections or mock audits. Your expertise will ensure that all documentation aligns with the latest EU GMP Annex 1 2022 revision expectations, making it submission-ready for regulatory agencies.
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 Life Science 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.
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