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    Job · 20515155

    HYDERABAD · FULLTIME

    QA IPQA (OSD)

    Sri Ambikare Pharma

    Sri Ambikare Pharma

    Hyderabad · onsite · Posted 12d ago

    Sourced fromFoundit
    Not disclosed3–5 yrsfulltimeHyderabad

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    Section · 01

    About this role

    . QA – IPQA (OSD)

    Qualification: B.Pharm / M.Pharm / M.Sc. Chemistry

    Experience: 3–5 years

    Department: Quality Assurance

    Core Area: IPQA – Pellets/OSD

    Vacancies: 6

    Email ID :[HIDDEN TEXT]

    Job Description

    • Perform in-process quality assurance activities for Pellets/OSD manufacturing operations such as dispensing, sifting, granulation, drying, blending, coating, and packing.
    • Monitor manufacturing activities to ensure compliance with GMP, SOPs, BMR/BPR and approved procedures.
    • Perform line clearance before starting manufacturing and packing activities.
    • Verify dispensing of raw materials and packaging materials as per approved documents.
    • Monitor and verify critical process parameters such as:
    • Dispensing, Sifting, Granulation, LOD/moisture, Particle Size, Blend time, Coating parameters
    • Review and verify Batch Manufacturing Records (BMRs) and Batch Packing Records (BPRs).
    • Ensure proper documentation and Good Documentation Practices (GDP).
    • Report and document deviations, incidents, OOS/OOT and process-related abnormalities.
    • Participate in CAPA, change control and investigation activities.
    • Perform shop-floor audits and ensure compliance with GMP requirements.
    • Verify equipment cleaning and cleaning-status labels.
    • Ensure proper identification and status labeling of materials, equipment and products.
    • Coordinate with Production, QC, Warehouse and other departments for quality-related activities.
    • Support batch release documentation and QA review.
    • Ensure compliance with applicable regulatory and company requirements.

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    Section · 02

    Skills

    shop-floor auditsbprSOPsCAPAChange ControlIn Process Quality AssuranceBmrGMP

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