Description:
Role Overview: Reporting to the Microbiology Lead, this role provides real-time QC oversight for Drug Substance/Drug Product manufacturing. It is a key position within Quality, directly supporting daily manufacturing activities to ensure compliance with cGMP and corporate/local SOPs.
Key responsibilities
- Provide QC support for technology transfer and commercial manufacturing operations.
- Review SOPs, risk assessments, change controls, and related documentation for DS/DP operations.
- Lead/participate in microbiology projects: microbial method validation and testing, environmental monitoring, organism identification, facility qualification, cleaning validation, and process validation.
- Perform microbial testing; support atypical/OOS investigations; drive/track change controls and CAPAs.
- Monitor and trend method performance with supervisors and cross-functional partners.
- Author technical documents: methods, protocols, validation/qualification plans and reports, SOPs.
- Offer technical guidance and assess/introduce new microbiology technologies.
- Support the Microbiology Lead in developing microbial control strategies, quality enhancements, and operational efficiency improvements.
- Communicate effectively and take a lead role in project management interactions with internal and external stakeholders (e.g., Quality Assurance, Regulatory Affairs, Analytical Development, clients).
- Serve as a primary point of contact for project coordination, including emails and client meetings.
- Prepare for and participate in regulatory inspections (e.g., FDA, EMA) and client/internal cGMP audits.
- Perform all tasks in compliance with applicable regulations, international standards, and company policies and SOPs.
- Other duties as assigned.
Education
- BSc in Microbiology or a related discipline.
- 1–3 years of relevant industry experience.