Quality Analyst

Company Description

Key Responsibilities:

• Responsible for processing and oversight of changes through the generation, justification, impact assessment, modification, review, approval, and implementation workflow. This includes but is not limited to SOPs, production records, test methods, specifications, protocols, reports, equipment, processes, material suppliers, facilities, computer systems etc.
• Responsible for processing of documents through the generation, modification, review, and approval workflow. This includes but is not limited to SOPs, production records, test methods, protocols, reports, labeling, etc. also, archival of records.
• Responsible for review/approval of all documentation associated with the establishment and configuration of GMP equipment including laboratory equipment. This includes any Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) documents.
• Responsible for tracking, trending, and reporting of quality metrics for site, regional, and global review. Trending as required by SOP, Corp. Standards, and/or regulations.
• Responsible for review/approval of all documentation associated with the establishment and configuration of a GMP computerized system. This includes all lifecycle documents.
• Responsible for Review of regulatory and quality compliance requirements and global procedures, performance of gap assessments, and establishment or improvement of SOPs covering all areas of applicability. Development and monitoring of corrective action plans where needed.
• Ensuring quality support to regulatory affairs as it relates to updates/changes to market authorizations.
• Review of all documentation (i.e. LIR, OOS, Change Controls, etc.).
• Ensuring and performing investigation into a product quality complaint with resolution including corrective and preventive actions and closure of the investigation.
• Ensure review, approval, and on time closure of the laboratory investigation / events with resolution including corrective and preventive actions along with effectiveness determination.
• Ensuring quality oversight of maintenance and calibration activities including facilities and equipment and any critical systems such as process water etc.
• Responsible for management of regulatory authority and other external compliance audits (e.g. Customer audits) including communication, tracking and resolution of observations. Management of communications with regulatory agencies including required reporting and resolution of any actions required by the agencies.
  

Qualifications

• Education: M.Sc. in Chemistry or B.Tech/BE (Chemical Engineering) or B.Pharma
• Experience: Minimum 10 years of experience in a regulated pharmaceutical environment.
• Preferred Industries: API / Pharma.
  

Make Your Mark with TAPI