Executive - Quality Control

RESPONSIBILITIES

• Review in process materials, raw materials, Intermediates, recovered materials, finished products, tech transfer samples and cleaning verification / validation samples using current specification, STP, GTP and associated wet chemistry and instrumental techniques as appropriate.
• Prepare and review specifications, sampling instructions, test methods, analytical work records and other QC procedures.
• Review instrumental analysis results according to Matrix of analyst / microbiologist validation.
• Prepare and review training matrix & training plans.
• Prepare and review cleaning validation / verification, Method validation, Method verification, Method transfer protocols and reports.
• Prepare and review study protocols and reports related to Quality control activities.
• Prepare & analyze various quality documents including SOPs, validation protocols and reports.
• Timely review calibration for QC instruments like HPLC, Analytical Balance, Ultra Micro Balance, PH meter, Conductivity meter, UV spectrophotometer and refractometer etc.
• Prepare, review and keep track of yearly calibration schedule, monthly calibration planner & preventive maintenance schedule.
• Track and follow up on Method Validation, Verification, and Analytical Method Transfer activities
• Plan, execute and review of Method Validation, Verification & Analytical Method
• Manage daily planning activities and timely review of QC testing data
• Coordinate with service engineers during preventive maintenance and breakdown of QC instruments.
• Verify the quality and compliance of laboratory chemicals, Reagents and Indicators.
• Review logbook entries and daily monitoring activities.
• Monthly audit trial review for instruments.

WORK RELATIONS

Interfaces: Internal

• Quality Assurance, Quality Control, EHS, HRA, Warehouse, Engineering

Interfaces: External

• External Vendors.

DESIRED SKILLS

• Proven experience in the Quality Control department of a reputable pharmaceutical organization.
• Hands on experience on QC Instrument Handling
• Complete understanding of operating instruments such as HPLC, GC, KF, IR, and pH meters.
• Strong analytical capabilities and learning attitude.
• Excellent interpersonal and communication skills