Spansules Pharmatech looking for Manager - QA (Formulations)
Spansules was established in the year 2000 and commenced commercial manufacturing of Pre-formulation Pharmaceuticals at Hyderabad. Today Spansules has a manufacturing facility within the premises of Pharmaceuticals hub of Hyderabad . The facility was equipped with sophisticated equipments like, fluidized bed coater, Extruders, Spheronisers etc.
We are one of the fastest growing organizations in the area of drug loaded Sustained and Delayed release pellets formulations. Constant product innovation based on understanding the market trends & matching the customer expectations are the food for instigating our innovative machinery. Adaptation to match the intent of customer requirements and withstand commitment to meet your time and quality requirements are keys to our growth which gives us an edge over our competitors.
Post: Manager - QA (Formulations)
• Establish, Document, Implement, Maintain comprehensive QMS and continuously improve in accordance with all aspects of cGMP and regulations
• Functioning in accordance with standard operating procedures.
• Monitoring Equipment cleaning, calibration premises GMP compliance.
• Supportive training for all personnel along with the respective department head.
• Creation maintenance and updation of documentation.
• Support internal and external Audits and Compliance.
• Improvising Eco-System in the Organization
• Recording various defects and maintaining their history.
• Supervision of Inprocess QA.
• Review and approval of specification, Test procedures of raw materials intermediates and finished products.
• Regulatory complainace.
• Query response and complaint handling.
• Vendor qualification.
• Review and Approval of all dept documents and SOP’s and change controls.
• Responsible for batch release of products.
• Overseeing of validation programs.
• Review of AMVP and AMVR and method transfer.
• Change control and Deviation control.
Experience: 5-7 Years
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: QA
End Date: 21th July, 2012
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