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QA Asst Manager
Anmol Chemicals
posted 19d ago
Job Role Insights
Fixed timing
Key skills for the job
Job Description
- QA Executive shall verify documents and facility as per existing procedures, cGMP and GLP in company premises.
- To issue the Batch Manufacturing Record, Equipment cleaning record, Logbooks, Analytical Report for raw material, finish product and packing material or any other documents.
- SOP preparation of different departments/ preparation of draft SOPs.
- Line Clearance activities for Production department before start of the process.
- To issue the Change control form, deviation form, Out of Specification form, Customer complaint form etc. as required from relevant dept.
- Review of Batch Manufacturing Record, Analytical reports/records and filling. After verification of all documents and release of finish product.
- To verify Pest control activities on daily basis and record.
- Monitoring of Temperature and Humidity of Finish goods store/ Packing Blending Area and record.
- Sampling activity of Finish product, stability, retained sample, In process and Rejected material.
- To prepare/Review BMR, MFR as per regulatory requirements.
- Distribution, retrieval and control of SOPs, documents/records of all department.
- To participate in internal audits, customer audit, regulatory inspection.
- To Attend Quality Review meeting as per schedule.
- To prepare documents records and monitoring of activities as per SOPs.
- To prepare protocol/Report Technology Transfer documents and Activity.
- To ensure data integrity as per procedure.
- To review Production, QC, QA, Store, Engineering and EHS activity.
- Data storage and gathering and trending of quality-related data for preparation of Annual Product Review.
- To prepare approved vendor list and maintain vendor qualification.
- To send samples to external agency or lab for testing.
- Conduct traceability Activity.
- Preparation and maintain CAPA log.
- To ensure that deviations, product recall, return goods and customer Complaints, OOS, OOT by CAPA and Root Cause analysis are investigated, fill up of report and log the same.
- To verify of process validation, cleaning validation and equipment qualification and to prepare protocol and report.
- To verify Analytical Method validation or verification.
- To investigate Returned Material and maintain the record.
- To investigate Product complaint and maintain the record.
- Ensuring compliance of the systems used for maintaining the equipment and calibrating equipment / instruments / preparation of schedule.
- To prepare a schedule and conduct training on cGMP, GLP and evaluation of the training.
- Providing training to all concerned on cGMP and on job specific or based on needs identified.
- Any other assignment/work allocated by Head QA.
- To ensure disposal of waste is carried out as per procedure.
- To Support the head of department in the environmental management work and reporting to the head of Department regarding how the environmental management work is continuing.
- Investigation of deviation/incident related to Environment management with co-ordination with head of department.
Employment Type: Full Time, Permanent
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What Anmol Chemicals employees are saying about work life
based on 8 employees
Strict timing
Monday to Saturday
No travel
Day Shift
Anmol Chemicals Benefits
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