Officer, QA Validation

RXinsider LTD.; Hyderabad; On-site; INR 400,000 - 900,000; Full time

Job summary

RXinsider LTD. in Hyderabad, India, invites qualified candidates with a B. Pharmacy to join our Quality Assurance division as a QA/Qualification Specialist.

You will oversee routine GMP compliance, documentation, and qualification activities on the manufacturing floor. Responsibilities include preparing and reviewing URS, DQ, and qualification documents, coordinating cross-functional qualification/validation with suppliers and equipment, and maintaining SOPs while ensuring calibration and risk

Qualifications

• GMP knowledge and documentation skills are essential.
• Experience with QA processes and validation activities.
• Experience with URS/DQ and qualification documents.
• Ability to coordinate with cross-functional teams for qualification/validation.

Responsibilities

• Monitor manufacturing areas for GMP compliance and record-keeping.
• Prepare and review validation/qualification protocols and reports.
• Coordinate qualification/validation activities with cross-functional departments.
• Develop and maintain SOPs for Quality Assurance.
• Review calibration and qualification documentation and approvals.

Skills

GMP knowledge

Documentation skills

Cross-functional work

QA coordination

Education

B. Pharmacy

Tools

QMS tools

Job description

Job Description

• Responsible for routine monitoring of Manufacturing Areas.
• Responsible for the routine GMP Inspection & review of Quality Records of other departments.
• To monitor and ensure compliance level of organization is as per current GMP requirement
• Good Documentation recording and updation.
• Responsible for review of URS, DQ and vendor / suppliers documents related to qualification.
• Responsible for preparation of Validation / Qualification protocol and report.
• Responsible for execution and review of qualification / Re-Qualification and Validation activity of Equipment / System / Facility and Plant Utilities.
• Responsible for adequacy of execution of validations being carried out at prescribed procedures.
• Responsible For Assurance Of Calibrations Before Performing Qualifications.
• Responsible to co-ordinate with cross functional department personnel for respective Qualification / Validation / Re-qualification activity for timely completion of activities.
• Responsible for preparation of Standard Operating Procedures of Quality Assurance Department.
• Responsible to check production shop floor compliance.
• Responsible for preparation and review of VMP.
• Responsible for preparation, review, execution data and compilation updation of validation related documents.
• Responsible for handling of failures during qualification by using QMS tools.
• Responsible for Preparation, review and execution of risk assessment activity related to Equipment / Process / Facility / System.
• Viable monitoring in clean area of manufacturing and warehouse as per the defined schedule.
• Responsible for personnel monitoring.
• Responsible to participate in qualification, requalification, area qualification activities.
• Calibration certification review and approval

Qualifications

Qualification - B. Pharmacy