14 Sep
|
cadchem laboratories
|
Dera Bassi
14 Sep
cadchem laboratories
Dera Bassi
Cadchem Laboratories Ltd
API Pharmaceutical Plant
QA Executive
Qualification : BSC / MSC or B.Pharma / M.Pharma
Experience : 1-3 years in Pharmaceutical Company
Key Responsibilities
Quality Assurance Operations
- Review and approve Batch Manufacturing Records (BMRs) and Batch Packing Records (BPRs).
- Ensure compliance with cGMP, ICH, WHO, USFDA, EU GMP, and other regulatory requirements.
- Monitor and ensure adherence to SOPs, policies, and quality systems.
- Perform line clearance and in-process checks during API manufacturing.
Documentation & Compliance
- Preparation, review, and control of SOPs, protocols, and formats.
- Review of analytical and manufacturing documents.
- Ensure proper documentation practices as per GDP (Good Documentation Practices).
- Maintain and update Quality Management System (QMS) documents.
Deviations, Change Control & CAPA
- Initiate, investigate, and close deviations, OOS, OOT, and incidents.
- Participate in root cause analysis and implementation of CAPA.
- Handle change control activities related to processes, equipment, and documents.
Validation & Qualification Support
- Assist in process validation, cleaning validation, and equipment qualification.
- Review validation protocols and reports.
- Ensure compliance of validation activities with regulatory guidelines.
Audits & Inspections
- Participate in internal audits, vendor audits, and regulatory inspections.
- Prepare and support regulatory audits (USFDA, WHO, EDQM, etc.).
- Assist in preparation of audit responses and compliance reports.
Training & Continuous Improvement
- Conduct GMP and SOP training for production and QC personnel.
- Support continuous improvement initiatives in QA processes.
Job Types: Full time, Permanent
Pay: ₹20,000.00 - ₹25,000.00 per month
Work Location: In person
📌 QA Executive (Dera Bassi)
🏢 cadchem laboratories
📍 Dera Bassi