Title:  Sr. Officer, QA

Sr. Officer – QA position, Job Responsibilities:

• Handle and approve deviations, investigations, and laboratory investigations.
• Ensure product compliance with specifications and cGMP requirements.
• Approve validation protocols/reports, process validation, stability protocols, APRs, and master batch records.
• Review and approve change controls.
• Perform risk assessments and review gap analysis reports.

• Conduct QA rounds, and in-process checks, documentation reviews, ensuring completeness and compliance.
• Create, update, and review SOPs, including periodic review cycles.

• Prepare and review CAPA and quarterly reports, ensuring effectiveness tracking.
• Issue and follow up on Quality Circles.
• Performs line clearance and area verification
• Monitors GMP compliance on the shop floor
• Reviews and approves batch manufacturing records (BMRs)
• Reviews equipment logs, cleaning logs, yield calculations
• Verifies sampling, dispensing, packaging activities
• Issues and receives labels, controlled documents

Qualifications:

• Bachelor’s degree with minimum 4 years of relevant work experience very good experience in deviations and investigations.

Specialized Skills:

• Veeva, Analytical Testing, Data Analysis, Data Integrity, LIMS, Laboratory Instrumentation
• GMP, SOPs, Safety Awareness
• Deviations, Investigations, Quality Auditing, Quality Control, CAPA, Change Control, Technical Writing, Validation

Behavioral Competencies:

• Collaboration & Teamwork, Initiative & Drive for Results, Resilience & Adaptability, Change & Innovation, Problem Solving & Decision Making