Manager - Production

Role Overview: You will be responsible for ensuring the readiness of equipment and instruments for the manufacturing process. Additionally, you will ensure the availability of process raw materials, accessories, and consumables in the process area before batch execution. Your role will also involve the preparation, review, and execution of various protocols and reports related to process, equipment, area qualification, and validation. Key Responsibilities: - Prepare and review process, equipment, and area related Standard Operating Procedures (SOPs) and Emergency Operating Procedures (EOPs). - Execute process, area, and equipment qualification/validation protocols. - Prepare various reports such as process, equipment, and area qualification and validation reports. - Prepare, review, and execute Batch Production Records (BPR) and handle their request and issuance. - Prepare, review, and execute study protocols. - Ensure the readiness of downstream areas and other manufacturing areas for operations. - Ensure smooth functioning of shop floor functions during manufacturing campaigns. - Raise and review change control and deviations as required. - Handle SAP related activities pertaining to process and maintenance. - Operate downstream equipment for the manufacturing process and Cleaning-in-Place/Sterilization-in-Place (CIP/SIP) processes. Qualifications Required: - M.Sc. or B.Tech with a post-graduation degree. - B.Tech in Biotechnology or Biochemistry. - 11 to 16 years of experience in biosimilar manufacturing, production planning, and Quality Management Systems (QMS). (Note: Additional details about the company were not included in the provided job description.) Role Overview: You will be responsible for ensuring the readiness of equipment and instruments for the manufacturing process. Additionally, you will ensure the availability of process raw materials, accessories, and consumables in the process area before batch execution. Your role will also involve the preparation, review, and execution of various protocols and reports related to process, equipment, area qualification, and validation. Key Responsibilities: - Prepare and review process, equipment, and area related Standard Operating Procedures (SOPs) and Emergency Operating Procedures (EOPs). - Execute process, area, and equipment qualification/validation protocols. - Prepare various reports such as process, equipment, and area qualification and validation reports. - Prepare, review, and execute Batch Production Records (BPR) and handle their request and issuance. - Prepare, review, and execute study protocols. - Ensure the readiness of downstream areas and other manufacturing areas for operations. - Ensure smooth functioning of shop floor functions during manufacturing campaigns. - Raise and review change control and deviations as required. - Handle SAP related activities pertaining to process and maintenance. - Operate downstream equipment for the manufacturing process and Cleaning-in-Place/Sterilization-in-Place (CIP/SIP) processes. Qualifications Required: - M.Sc. or B.Tech with a post-graduation degree. - B.Tech in Biotechnology or Biochemistry. - 11 to 16 years of experience in biosimilar manufacturing, production planning, and Quality Management Systems (QMS). (Note: Additional details about the company were not included in the provided job description.)