QA Manager

4 hours ago

Gwalior, India Amrutam Full time

About Us Amrutam is a pioneering Ayurvedic lifestyle and wellness platform that blends the ancient wisdom of Ayurveda with the convenience of modern technology. Founded with a vision to make holistic health accessible and trustworthy, Amrutam offers a range of authentic Ayurvedic products and services – from doctor consultations to wellness content – all in one place. Job Details Base Location :- Gwalior Department:- Q.A. Manager Working Mode:- In Office Experience:- 3  years (mandatory) Qualification:- Bachelor's degree in B. Pharma & M. Pharma or related field Reporting:- Head – Q.A. AND Q.C. CTC:- As per market standard Leve:- Entry Key Responsibilities 1. Ensuring GMP Compliance (Ayurveda-Specific) Ensure compliance with Schedule T of the Drugs and Cosmetics Act, which governs GMP for Ayurvedic, Siddha, and Unani medicines. Monitor hygienic conditions of raw material handling, processing, packaging, and storage. Verify adherence to SOPs for traditional methods like churna, chyawanprash /Avleh , bhasma,, oil  etc.  2. Raw Material Quality Assurance Ensure proper identification and authentication of raw herbs and minerals. Check source and documentation (e.g., COA – Certificate of Analysis) for each ingredient. Conduct tests for adulteration, pesticide residues, heavy metals, and microbial load as per AYUSH or pharmacopoeia standards.  3. In-Process Quality Checks Monitor critical stages in preparation such as: Shodhana (purification of metals/minerals) Bhavana (trituration) Mardana (grinding) Putapaka (incineration for bhasmas) Ensure each step follows documented traditional and regulatory methods.  4. Batch Manufacturing Record (BMR) Review Verify and review Batch Manufacturing Records for each Ayurvedic product. Ensure proper documentation of each process step and material used. Approve or reject batches based on compliance.  5. Packaging and Labeling Verification Check packaging material quality (e.g., bottles, cap, packs, labels). Ensure labels comply with Ayurvedic Drug Labeling Rules, including: Manufacturer details Composition (with Latin/botanical names) Dosage Indications License number  6. Finished Product Quality Assurance Review test results for finished products: Organoleptic properties (color, odor, taste) Physico-chemical parameters (pH, ash value, etc.) Microbial testing Shelf-life study Approve or reject batches accordingly.  7. Deviation, CAPA & Complaint Handling Handle deviations during production or packaging. Initiate CAPA for quality issues. Address customer complaints and conduct root cause analysis.  8. Training & SOP Management Conduct GMP and SOP training for production and warehouse staff. Prepare and update SOPs for all quality-critical activities.  9. Regulatory Compliance & Audits Ensure adherence to AYUSH, State FDA, and Pharmacopoeial guidelines. Prepare for and assist in regulatory inspections. Coordinate documentation for product license, renewals, and audit responses.  Key Skills and Knowledge Areas: Understanding of Ayurvedic raw materials, formulations, and processing techniques. Familiarity with AYUSH regulations, Schedule T, and Pharmacopoeia of India (API). Basic knowledge of microbiology and herbal quality testing. Good documentation and audit readiness practices  Daily checklist or a QA SOP format for an Ayurvedic manufacturing unit? Skill Requirements All working According to  GMP  (Ayurveda – specific)  BMR and BPR with all documents with control 

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