Sun Pharma | Walk-In for Multiple Positions | 7th October 2018 | Indore

Key Responsibilities

• Develop knowledge of and understand regulatory requirements such as 21CFR part 210 and 211, cGMP’s, FDA, OSHA and other regulatory agencies.
• Understand site Standard Operating Procedures (SOP’s) and cGMP’s relative to the positions within APA, and partner with Quality to ensure processes and products are in compliance with all local, state, and federal rules and regulations.
• Participate in all aspects of Manufacturing within the APA / processes.
• Set-up, Operation, and troubleshooting of key manufacturing equipment: including (but not limited to) lyophilizer, autoclave, washers, filler, capper, CIP/SIP skid, etc.
• Training compliance and ability to train new/less experienced Operators.
• Assist in the execution of equipment/process qualification, validation, and protocols.
• Assist in development and creation of departmental Standard Operating Procedures (SOP’s).
• Perform tasks as per established Good Documentation Practices, and review of executed documentation (batch records, logbooks, etc.) prior to the end of the shift.
• Ensure that daily production is running efficiently, both in terms of output and quality.
• Oversee that processes are in cGMP compliance, and establish systems that identifies opportunities for improvement and makes constructive suggestions for change to improve process effectiveness to heighten quality.
• Participate in investigations, and execute appropriate approved corrective / preventative actions for APA Core / related processes.
• Ensure that the current requirements for Environmental, Health and Safety (EHS) issues are met within the production operations.
• Include relevant stakeholders in decision-making in regards to equipment, processes and other daily operations.
• Work methodically with an acute awareness of the direct and indirect impact of all actions performed.
• Personnel engaged in the manufacture, processing, packing, or holding of a drug product shall wear clean clothing appropriate for the duties they perform. Protective apparel, such as head, face, hand, and arm coverings, shall be worn as necessary to protect drug products from contamination.

WhatsApp Group

 
Join our WhatsApp group