Jobs

Description

Core Hours will be between 8 am-5pm Mon-Fri

This position is part-time 20 - 30 hours per week

Open for candidates who are ready to relocate at their own expense

• Bachelors degree needed minimum or 5 yrs of relevant exp needed
• Will help the client with audit findings
• Strong knowledge of pharma manufacturing exp
• CAPA exp to do investigations
• This is a senior level role so candidates wit more exp needed
• Internship or academic exp will not be considered
• Pharma or medical device industry exp needed
• Strong deviation or lab investigations exp will be considered
• 21 CFR Part 210/211 is strongly preferred
• ICH Q9
• Need help with pharma combination product so strong pharma background needed

Temporary (6-month) contract

Must Have

• 21 CFR Part 210/211
• BS in scientific/technical field (or equivalent experience)
• Direct CAPA authoring
• Investigation writing
• Pharmaceutical/Drug Manufacturing
• Technical Review

Nice To Have

• Cleaning Validations
• Equipment Validation, Transfer, and Qualification
• ICH Q9
• OOS Investigations
• Supplier Assurance

Job Description

•  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)