15h Left! Assistant Production Manager

Department : Production ( Injectable )

Designation : Assistant Manager

Experience : 7 to 10 Years

Location : Bavla, Ahmedabad

Education : M. Pharma, B. Pharma, M. Sc

Job Description :

• To Follow the growing procedure during and exit in clean room, manufacturing and in autoclave area.
• To Follow the personal hygienic and clean room behavior in the production area.
• To responsible For All type of activity performed in dispensing and manufacturing area.
• Before dispensing reverification of calculation of API and ensure same to be reverified by IPQA.
• To Ensure the dispensing Of API and Excipients is as per respective BMR and Related SOPs.
• To reverify the dispensed API before Start of Manufacturing Operation.
• To Check and performed the CIP and SIP of Manufacturing tank to use for Manufacturing and holding of batch.
• To check the calibration and qualification status of tank before start of manufacturing.
• To take the line clearance form IPQA Before start of manufacturing operation.
• To Complete of documents Of Ongoing operations in Dispensing and Manufacturing Area.
• To Inform to Production Manager for Dispensing and Manufacturing related activities.
• To ensure the area monitoring, cleaning & Sanitization of all classified and non- classified area, temperature & %RH Monitoring in all production area.
• To Follow the clean room behavior in aseptic area and to train the people who area working in classified area about aseptic area behavior and aseptic practice.
• To perform dispensing and manufacturing of products as per procedure mentioned in BMR.
• To operate the Manufacturing vessel in manufacturing area as per defined procedure.
• To inform the Production Manager for breakdowns if any and to intimate the engineering department through defined procedure for breakdowns if any.
• Ensure to send the wash water during product change or batch change as per defined in SOP.
• To check and control all critical parameters during batch manufacturing.
• To make entry in Pharma Cloud software as per production activity. To intimate the IPQA personnel to collect and send. the bulk sample to QC at the end of batch manufacturing.
• To do online documentation in logbooks and BMR.
• To prepare and review of SOP of Production area as per regulatory and CGMP requirements.
• Prepare and revised the BMR for new and existing products.
• To co-ordinate with dispensing area personnel for the dispensing of raw materials.
• To co-ordinate with filling area personnel for their filtration of product solutions.
• To intimate QC department for bulk testing of product in advance.
• To co-ordinate with QC department for bulk testing.
• To co-ordinate with QA department for line clearance related activity, Qualification, Validation and Media fill related activity.
• To co-ordinate with engineering department for routine maintenance and preventive maintenance related activity.
• To implement continuous improvement for all production activity as suggested.
• To participate in execution of qualification and validation activity in accordance with QA and Engineering department.
• To give awareness and SOPs training to the the personnel working in Dispensing and manufacturing area
• To prepare requisition slip for outside maintenance 'work of machine or machine parts.
• Do all other work given by management as and when required. Ensure to always follows the safety norms of plant.

Transportation and Canteen Facility Available.

Regards,

Pruthviraj Mandora

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