13 Sep
|
Manvik Placement
|
Roorkee
13 Sep
Manvik Placement
Roorkee
Document Control: Drafting, reviewing, and approving Standard Operating Procedures (SOPs), work instructions, and master batch records while controlling version distribution and archival. [1] (https://www.pharmaguideline.com/2016/10/quality-management-system-qms.html), [2] (https://www.scilife.io/blog/qms-in-pharma-guide), [3] (https://www.labmanager.com/an-introduction-to-pharmaceutical-qa-quality-assurance-34022), [4] (https://www.dotcompliance.com/blog/pharmaceutical-manufacturing/pharmaceutical-qms-quality-management-system/)Batch Record Review: Inspecting executed Batch Manufacturing and Packing Records (BMR/BPR) to verify that every production step meets pre-set parameters before product release. [1] (https://pharmaceuticalupdates.com/2019/01/26/responsibility-of-quality-assurance-personnel-or-quality-unit-in-pharmaceuticals/)Change Control Management: Evaluating and authorizing any modifications made to equipment, raw materials, or manufacturing processes to assess and mitigate impact on product quality. [1] (https://www.pharmaguideline.com/2016/10/quality-management-system-qms.html)Deviation and CAPA Handling: Investigating non-conformances, identifying root causes,
and documenting Corrective and Preventive Actions (CAPA) to prevent issue recurrence. [1] (https://www.pharmaguideline.com/2016/10/quality-management-system-qms.html), [2] (https://pharmaceuticalupdates.com/2019/01/26/responsibility-of-quality-assurance-personnel-or-quality-unit-in-pharmaceuticals/)Validation and Qualification: Approving protocols and reports for equipment installation (IQ/OQ/PQ), cleaning validation, and computerized systems. [1] (https://jdpharmaconsultants.co.in/pharmaceutical-plant-documentation/quality-management-system-qms-documentation/), [2] (https://www.labmanager.com/an-introduction-to-pharmaceutical-qa-quality-assurance-34022)Audit and Inspection Readiness: Maintaining audit trails and preparing documentation files for internal quality audits and external
Pay: ₹20,000.00 - ₹50,000.00 per month
Benefits
- Commuter assistance
- Versatile schedule
- Paid sick time
- Provident Fund
Education:
- Bachelor's (Required)
Experience:
- Qms: 4 years (Required)
Work Location: In person
📌 Qa QMS documentation only pharma background (Roorkee)
🏢 Manvik Placement
📍 Roorkee