Lab Instrumentation (Validation/Qualification SMEs)

We are looking for people who have demonstrated proven success in roles and through abilities in Instrument Qualification, Computerized System Validation, cloud Qualification, Risk management and Quality Management

• Candidates with 7-10yrs experience who are able to work on-site in Boston, MA.
• Understand and able to review vendor Qualification document package in line with regulatory requirements
• Should be aware of USP 1058 – classification of instruments
• Know how in instrument qualification process and regulations
• Knowledge on unidirectional, Bidirectional and file based parsing scripts
• Knowledge on LIMS – Lab vantage, Labware, Watson etc.….
• Knowledge on Analytical lab instruments like HPLC, GC, GCMS, LCMS, FTIR, UV, Stability chamber, Spectrophotometer, TOC, plate reader ELISA, PCR, Xray   etc.…
• Know how integration manger works
• Knowledge on Chromeleon, Empower, ICDAS, SDMS, ELN, LES etc.…
• Knowledge on Instrument integration using RS232, USB, wireless etc.…
• Good Knowledge on Calibration of instruments
• Understanding of key pharmaceutical compliance regulations like Computerized System Validation, 21 CFR part 11, GxP, GAMP 5, SOX IT, Data Privacy, Data Integrity, and Information Security
• Knowledge on new regulations -Enable innovations, Quality by design, CSA, and AI ML
• Subject matter expertise in areas such as Quality Management, document management and Change Management
• Knowledge of Risk management perform root cause analysis on trends and address deviations via preventive, detective, and corrective measures
• Knowledge and hands on experience conducting periodic or control maturity assessment and Audits
• Knowledge of various Validation tools and templates used throughout the pharmaceutical industry
• Technical Writing Experience
• Work according to SOPs and GMP Regulations
• Excellent speak up mentality and feedback skills
• Basics of project leading skills

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