02 Oct
|
Maya Biotech
|
Baddi
02 Oct
Maya Biotech
Baddi
We are looking for a Sr. Executive QA Equipment Validation to manage and review equipment qualification and validation activities in compliance with cGMP, regulatory requirements, SOPs, and quality standards.
Key Responsibilities
- Execute/review DQ, IQ, OQ and PQ activities for pharmaceutical manufacturing and laboratory equipment.
- Prepare and review URS, validation protocols, qualification reports, risk assessments and related documents.
- Ensure equipment qualification activities are performed as per approved protocols and timelines.
- Review equipment specifications, drawings, manuals, calibration and maintenance records.
- Coordinate with Engineering, Production, QC, QA and vendors for qualification activities.
- Review and manage deviations, discrepancies, CAPA and change controls related to validation.
- Ensure proper documentation and compliance with GMP,
data integrity and validation requirements.
- Support periodic review, requalification and validation lifecycle management.
- Participate in internal, customer and regulatory audits/inspections and provide validation-related documentation.
- Maintain validation trackers and ensure timely closure of qualification activities.
Required Skills
- Positive knowledge of equipment qualification, validation lifecycle and GMP requirements.
- Hands-on experience with IQ/OQ/PQ, risk assessment, deviation, CAPA and change control.
- Strong documentation and report-writing skills.
- Good coordination and communication skills with cross-functional teams.
- Experience in a pharmaceutical manufacturing environment is preferred.
📌 QA Equipment Validation (Baddi)
🏢 Maya Biotech
📍 Baddi