What are the responsibilities and job description for the Engr 3, Quality position at Planet Pharma?
Must Have
Requirements
GMP professional to support CAPA deliverables as part of a broader quality remediation initiative, bringing strong knowledge of 21 CFR Part 211 requirements and demonstrated expertise in technical writing and document review within a regulated environment. The ideal candidate will be capable of independently driving high-quality, inspection-ready outputs while partnering with cross-functional teams and contributing to a risk-based approach to compliance, with additional value placed on familiarity with ICH Q9 principles — key capabilities include:
- 21 CFR Part 210/211
- BS in scientific/technical field (or equivalent experience)
- Direct CAPA authoring
- Investigation writing
- Pharmaceutical/Drug Manufacturing
- Technical Review
- Cleaning ValidationsEquipment Validation, Transfer, and Qualification
- ICH Q9
- OOS Investigations
- Supplier Assurance
Requirements
GMP professional to support CAPA deliverables as part of a broader quality remediation initiative, bringing strong knowledge of 21 CFR Part 211 requirements and demonstrated expertise in technical writing and document review within a regulated environment. The ideal candidate will be capable of independently driving high-quality, inspection-ready outputs while partnering with cross-functional teams and contributing to a risk-based approach to compliance, with additional value placed on familiarity with ICH Q9 principles — key capabilities include:
- Develop and execute CAPA records, ensuring alignment with regulatory expectations and internal quality standards
- Perform thorough technical writing and critical review of investigations, protocols, and reports
- Apply 21 CFR Part 211 knowledge to ensure GMP compliance across deliverables and identify potential risks or gaps
- Collaborate with SMEs and functional teams to drive timely closure of CAPAs and maintain project timelines
- Additional desired skills in risk assessment and risk management to contribute to or author/review risk assessments using a structured, science- and risk-based approach (ICH Q9 experience preferred)