Officer - Quality Control

RESPONSIBILITIES

• Responsible for review of In process, 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.
• Responsible for review of instrumental analysis as per the Matrix of analyst / microbiologist validation.
• Preparation and review of training matrix & training plan.
• Prepare and review cleaning validation / verification, Method validation, Method verification, Method transfer protocols and reports.
• Prepare and review study protocol and report for Quality control activities
• Preparation & review various quality documents such as SOPs, validation protocols and reports.
• Responsible for review of calibration of QC instruments like HPLC, Analytical Balance, Ultra Micro Balance, pH meter, Conductivity meter, UV spectrophotometer and refractometer etc
• Responsible for preparation, review, tracking of yearly calibration schedule, monthly calibration planner & preventive maintenance schedule.
• Ensure the tracking and follow up for the Method Validation, Verification & Analytical Method Transfer Activity.
• Planning and Execution of Method Validation, Verification & Analytical Method
• Coordinate with service engineer during preventive maintenance and breakdown of QC instruments.
• Responsible for verification of Laboratory chemicals, Reagents and Indicators.
• Review of logbooks in Quality Control Department and Responsible for monthly audit trial review for instrument.

WORK RELATIONS

Interfaces: Internal

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

Interfaces: External

• External Vendors.

DESIRED SKILLS

• Must have experience in Quality Control department in reputed pharma organizations.
• Should have hands on experience of Instrument Handling
• Strong knowledge of operating HPLC, GC, KF, IR, pH Meter etc.
• One Should Manage day to day Planning
• Should review method validation, Verification & Analytical Method Transfer Activity.
• One should timely review of calibration / verification of instruments.
• Ensure timely review preventive maintenance of instruments.
• Should review of records of QC testing.
• One should Timely review of logbook entries & daily monitoring activities.