AUROBINDO PHARMA LTD' (APL). APL is a growing Indian multinational pharmaceutical manufacturing firm with turnover of over US$2.8 Billion revenues for 2018-19, with presence in more than 34 countries fronted presence with products exported to 155 nations. APL is 2nd Largest Generic Company as per Rx dispensed in the USA.APL is Amongst Top 10 Generic player in France, Germany, Portugal, UK, Italy, Czech Republic, Netherlands & Belgium. APL manufactured 33 Billion+ diverse dosage forms in 2018-19. APL has 27 manufacturing facilities and 5 R&D centres worldwide.
Post : Executive/Sr.Executive-IPQA-Injectable-formulation
Job Description
1. Preparation and review of batch manufacturing and batch packing records for all lines, ensuring compliance as per various regulatory requirements.
2. Preparation and review of IPQA related SOPs.
3. Monitoring of manufacturing activities by in process checks, sampling and ensure on line documentation.
4. Ensuring and providing timely line clearance for each of manufacturing activities stage wise.
5. Coordination in collection of samples for validation, stability, QC and any others if any.
6. Monitoring and ensuring effective implementation of entry exit, personnel hygiene and gowning procedure.
7. Timely reporting of the incidents, deviations, change controls with respect to shop floor activities for necessary compliance.
8. Monitoring and ensuring effective implementation of cGMP and GDP.
9. Ensuring the effective implementation of all required procedures (SOP's) and practices of production, engineering, warehouse, housekeeping for SISPQ of products
10. To be part of process simulation study for effective implementation of protocol and related activities.
11. Verification of various log books of production, engineering, warehouse etc., for regular compliance.
12. Monitoring shop floor qualification activities of personnel, equipment, facilities.
Candidate profile
• Candidate must have experience in IPQA Injectable.
• Must have regulatory Exposure.
Additional Information
Experience : 2-7 years
Qualification : B.Pharm, M.Pharm
Location : Hyderabad
Industry Type : Pharma
Functional Area : IPQA-Injectable-formulation
Last date : 20th July, 2020
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