Senior Specialist Quality Assurance - III

Education Requirements:

BS in Biology, Microbiology, Pharmacy, Chemistry, Chemical Engineering, or equivalent field.

Required Experience and Skills:

• Minimum 5 years of experience in the Pharmaceutical Industry.
• Working knowledge of regulatory expectations for the manufacture and testing of sterile pharmaceutical products.
• Experience in quality assurance oversight of sterile manufacturing, sterile process validation, and/or sterile process technology transfer.
• At least 3 years of experience in the development, review, and approval of User Requirements Specifications (URS), Factory Acceptance Testing (FAT), Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) for pharmaceutical and biotechnology manufacturing equipment, facilities, and utilities.

Preferred Experience and Skills:

Experience in the assessment and preparation of manufacturing sites for Pre-Approval Inspections by Regulatory Agencies for new products.

Core Responsibilities:

• Independently manage project assignments reporting to the Quality Assurance Organization.
• Provide immediate project support through the review and approval of commissioning and qualification (C&Q) documents.
• Critical and constructive review and approval of GMP documentation such as Quality Agreements, Quality Risk Assessments, URS, FAT, IQ, OQ, PQ, technical documents, change management records, and manufacturing/batch documentation to meet schedule milestones.
• Ensure all aspects of projects proceed in compliance with cGMP, regulations, and the Company's Quality Management System.
• Focus on Qualification and Compliance areas covering Manufacturing Equipment (e.g., isolators, restricted access barriers, incubators, washers, autoclaves, formulation vessels, lyophilizers).
• Review and approval of master batch records, executed records, technical protocols, investigations, change controls, SOPs, validation protocols, and technical reports.
• Consult with next-level management on more complex decisions as needed.

Additional Skills:

• Strong interpersonal, communication, negotiation, and persuasion skills.
• Exceptional relationship-building capabilities.