Job highlights
Prepare the production process SOPs & batch records
Initiate plans and processes which minimize manufacturing costs . On line completion and reviewing of the batch records and documents
.

Higher

Educational background in Pharmacy . Min 5 years of experience in Production department in Aseptic operations

:
Higher Educational background in Pharmacy
Min 5 years of experience in Production department in Aseptic operations
Understanding of equipment like Steam Sterilizer, Dry heat sterilizer, Washing Machine, Filling Machine, Lyophilizer, HVAC, water system, compressed air, Nitrogen system etc.
Understanding on Process Validation for Sterilization, Washing, Aseptic filling, and cleaning procedures.
Knowledge for evaluation of change control, deviation, and incident, out of specification, out of trend and risk management.
Prepare the production process SOPs & batch records
Knowledge for goods manufacturing practices and capacity to provide the training to all concerns.
Knowledge on Aseptic processes, Lean, OEE and similar KPIs.




Hands-on experience for any of regulatory audits such as US FDA, UK MHRA, ANVISA Brazil ,TGA - Australia or MCC South Africa plant experience will be having an added advantage.

Duties and Responsibilities
To control the production activities
To ensure schedules are adhered to commitments
To ensure high standard of housekeeping and cleanliness in low bio burden area.
To ensure that production is done as per defined procedure & specifications
To monitor and control the yield losses during the production process.
Initiate plans and processes which minimize manufacturing costs
On line completion and reviewing of the batch records and documents.
Preparation & review of SOPs of the production sterile operations
Imparting on the Job training to executive and technician about the sterile operations.
Coordinating with QA and QC for validation and in-process checks and approvals.
In the title section write down the position you are applying! We will be waiting to hear from you soon!

📌 Assistant Manager / Sr Executive Production Sterile Surat
🏢 Arkray Healthcare
📍 Surat