QA Manager Job in Gwalior West at Amrutam Pharmaceuticals

About the Job

Key Responsibilities:

A. Ensuring GMP compliance ayurveda specific:
1. Ensure compliance with Schedule T of the Drugs and Cosmetics Act which governs GMP for Ayurvedic Siddha and Unani medicines
2. Monitor hygienic conditions of raw material handling processing packaging and storage
3. Verify adherence to SOPs for traditional methods like churna chyawanprash, avleh bhasma and oil preparations

B. Raw material quality assurance:
1. Ensure proper identification and authentication of raw herbs and minerals
2. Check the source and documentation including COA for each ingredient
3. Conduct tests for adulteration pesticide residues heavy metals and microbial load as per AYUSH or pharmacopoeia standards

C. In Process quality checks:
1. Monitor critical stages in preparation such as shodhana purification bhavana, trituration, mardana grinding and putapaka incineration for bhasmas
2. Ensure each step follows documented traditional and regulatory methods

D. Batch manufacturing record BMR review:
1. Verify and review batch manufacturing records for each Ayurvedic product
2. Ensure proper documentation of each process step and material used
3. Approve or reject batches based on compliance

E. Packaging and labeling verification:
1. Check packaging material quality including bottles, caps, packs and labels
2. Ensure labels comply with Ayurvedic drug labeling rules including manufacturer details, composition, dosage indications and license number

F. Finished product quality assurance:
1. Review test results for finished products including organoleptic properties, physicochemical parameters, microbial testing and shelf life studies
2. Approve or reject batches accordingly

G. Deviation CAPA and complaint handling:
1. Handle deviations during production or packaging
2. Initiate CAPA for quality issues
3. Address customer complaints and conduct root cause analysis

H. Training and SOP management:
1. Conduct GMP and SOP training for production and warehouse staff
2. Prepare and update SOPs for all quality-critical activities

I. Regulatory compliance and audits:
1. Ensure adherence to AYUSH State FDA and pharmacopoeial guidelines
2. Prepare for and assist in regulatory inspections
3. Coordinate documentation for product licenses, renewals and audit responses

Note: All working according to GMP (Ayurveda–specific) BMR and BPR, with all documents under control

Number of Openings

1 openings

Skills

Problem Solving