- Manage analytical methods development, validation, and tech. transfers from R&D to QC and manufacturing sites
- Design and prepare method validation protocols for APIs, finished products, and impurities/degradants
- Prepare regulatory filings (ANDAs, INDs, NDAs, DMFs) in the CTD format including QbRs
- Provide project management services (early to late stage development)
- Design, implement, and evaluate laboratory systems, procedures, and controls
- Perform simulated FDA pre-approval inspections
- Review Laboratory Investigation Reports (LIRs) along with GMP impact statement and CAPA assessment
- Review Manufacturing Batch Records (MBRs) along with MIRs (Manufacturing Investigation Reports) with a goal to assess
appropriate regulatory actions/filings
- Review change controls and deviations
- Review SOPs to determine their compliance according to ICH and FDA guidelines
- Review laboratory instrument calibration and preventive maintenance records for cGMP compliance
- Review IQ/OQ/PQ data and documentation
- Review OOT and OOS results and assess justifications based on assignable cause
- Review electronic laboratory data and audit trails
- Review FDA 483 observations and assess product impact based on methods, protocols, validation data, and specifications
- Perform data integrity check and assess batch release criteria and compliance to cGMP and other guidelines
- Perform due diligence audits enabling clients to acquire companies, products, and technology platforms
- Restructure R&D/QC operations to improve both quality and productivity