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