Manager - Quality Assurance (delhi) en SAP Business Technology Platform
SAP Business Technology Platform · Delhi, Indien · Onsite
- Senior
- Oficina en Delhi
Brief Requirements:
- Should have faced International Audits.
- Should have been conducting audits of manufacturing locations & Vendors.
- Should have worked in shop floor and have sound process knowledge in manufacturing of Semisolid, Solid oral, Liquids & powder dosage forms.
- Should have thorough understanding of GMP guidelines and regulations applicable to Pharma, Personal Care, and food products.
- Should be well versed with ERP systems like SAP, LIMS, etc.
- Should have detailed process understanding and should have handled team directly.
Role Expectations:
- Should be able to lead the overall contract Mfg. activities for manufacturing of Pharma, Cosmetics & Food products.
- Should be able to review & perform critical activities on his / her own.
- Should be able to travel for GMP compliance and investigational audits.
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S.No. |
RESPONSIBILITY |
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01 |
Responsible for implementing and ensuring Quality & Compliance at Contract Manufacturing Locations. |
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02 |
To ensure audits of CMLs, Vendors, external laboratories, are carried out and compliance is verified. |
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03 |
To ensure effective Quality Management systems like Change controls, Deviations, Out of Specification, Market complaints, Training, etc. are followed. |
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04 |
Responsible to ensure organisations Quality objectives are met & compliance is achieved. |
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05 |
Responsible to visit contract manufacturing locations regularly and to ensure risks are mitigated which may leading to non-conformances & product failures. |
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06 |
To ensure product failures, market complaints, non-conformances are investigated thoroughly, and compliance is maintained. |
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07 |
Responsible to ensure CAPA system and CAPA effectiveness is achieved. |
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08 |
Responsible to implement Quality rating system for contract manufacturing locations on ensuring performance of each site. |
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09 |
Ensure effective & timely escalations of failures with management and to address the issues. |
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12 |
Review and approval of SOPs and Validation Protocols & reports. |
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14 |
Review and approval of Master formula records (MFR’s), Batch manufacturing & packing records. |
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15 |
Review and approval of Batch manufacturing & packing records. |
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16 |
Review and approval of stability Protocols & reports |
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19 |
Coordination with CML, Vendors, External laboratories, R&D, Production & other concern personnel in meeting compliance activities. |
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20 |
Supervision and monitoring of day-to-day activities Quality assurance and to review the performance. |
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21 |
Training of subordinates & CML teams on good manufacturing practices, Data Integrity, Good laboratory practices. |
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22 |
Ensure monthly reports are generated and are reviewed. |
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23 |
Participate & conduct Quality review meetings on addressing the Quality Improvement Plan. |
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