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Indian Immunologicals (IIL) is seeking a seasoned QA professional with extensive Ayurvedic manufacturing and GMP experience to join our quality assurance team in Hyderabad. The role emphasizes rigorous material, in-process, and finished product testing, along with thorough documentation reviews and compliance with AYUSH regulations.
The candidate should possess senior-level knowledge of quality systems, audits, and data integrity, with robust analytical skills for methods like HPLC/GC/UV and
BAMS / B.Pharm (Ayurveda) / M.Pharm (Ayurveda) / equivalent qualification relevant to Ayurvedic medicines
25 years of experience in Ayurvedic medicine manufacturing, Quality Control, or Quality Assurance
Good understanding of Schedule T Ayurvedic GMP requirements, applicable AYUSH regulations and quality systems
Knowledge of testing of raw materials, in-process materials and finished Ayurvedic products
Ability to review BMR/BPR, specifications, STPs, COAs, test reports, logbooks and other GMP documents
Identification, sampling, testing and evaluation of herbs, botanical materials, excipients and other Ayurvedic ingredients
Understanding of Ayurvedic dosage forms such as tablets, capsules, powders, syrups, oils, ointments, etc.
Knowledge of deviations, OOS/OOT, CAPA, change control, complaints, recalls, risk assessment and self-inspection
Knowledge of supplier qualification, material qualification and review of vendor documents/COAs
Familiarity with Ministry of AYUSH / State Licensing Authority requirements, applicable pharmacopoeial requirements and GMP expectations
Awareness of ALCOA+ principles and good documentation practices
Ability to participate in internal, supplier and regulatory audits and prepare compliance responses
Basic understanding of HPLC/GC/UV/IR, microbial testing, heavy metals, aflatoxins, pesticide residues and other applicable tests
MS Word, Excel and electronic quality/document management systems
Attention to detail, analytical thinking, communication, investigation and decision-making skills