CQV Lead/ Engineer (OSD/Injectables Process Equipment Qualification

Responsibilities

• Develop CQMP, VMP, FRA, cGMP review sheet, interdependencies
• Develop System boundary, URS, SCA/SLIA, CLIA, DQR, SRA/QRA, SAT protocol, commissioning protocol, IQ protocol, OQ protocol, PQ protocol.
• Develop process validation and cleaning validation protocol
• Execute Commissioning, qualification and validation activities for Pharma Process Equipment’s for API, Fill/Finish and OSD.
• Review, analyze and interpret system performance data for completed validation and prepare final report packages by summarizing the data.
• handling of deviation/ discrepancy, Investigation , CAPA .
• Promote cGMP and regulatory compliance into assigned projects.
• Exercise GDP, ALCOA, practice while execution.
• Exercise good judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions.
• Hands on Experience with Pharma Process Equipments.
• Drafting of equipment operation SOP’s
  

Qualifications & Other Requirements

• BS/MS in Engineering (Chemical, Pharma).
• 4-10 years in validation, quality systems, operations, engineering or any combination thereof.
• Experience in multiple GMP validation disciplines with advanced technical knowledge.
• Validation experience using , traditional, risk based, Hybrid approach.
• Knowledge of Validation Lifecycle approach (URS, FRS, FAT/SAT, Commissioning IQ, OQ, & PQ Protocols, etc.) guidelines, international regulatory requirements and standards.
• Experience working with Documentum or Maximo a plus.
• Experience interacting with or creating material for representatives of regulatory agencies and executive level staff.
• Experience with investigations into manufacturing deviations and determination of product impact potential, root cause and corrective actions.
• Strong verbal and written communication skills; excellent organizational and time utilization skills
• Ability to work independently and within project teams.
• Industry experience related to cGMP drug manufacturing, validation, and chemical process design
• Strong computer knowledge including Microsoft Office products