Company: Dr. Reddy’s Laboratories
Location: Pydibimavaram, India
Industry Type: Pharmaceuticals / Healthcare / Clinical Research
Functional Area: Formulation R&D
Qualifications: M.Pharmacy / B.Pharmacy
Application End Date: 25th January 2025
About Dr. Reddy’s Laboratories: Dr. Reddy’s Laboratories is a leading Indian multinational pharmaceutical company, headquartered in Hyderabad, Telangana, India. Founded by Kallam Anji Reddy, the company operates in the global pharmaceutical market, providing high-quality generic medicines.
Job Description:
As an MSAT Team Member, you will be responsible for several critical activities related to product transfer, process qualification, and technology absorption at the FTO – SEZ Process Unit 1 for Nasal products. You will play a key role in ensuring the smooth execution of product transfers, process validations, and investigations for quality improvements.
Key Responsibilities:
- Product Transfer and Technology Absorption:
- Oversee the execution and monitoring of confirmatory, submission, pre-validation, and process qualification batches.
- Conduct process simplifications, handle machine changes, batch size changes, and other routine validation activities.
- Investigation and Root Cause Analysis:
- Handle investigations arising from incidents, out-of-specifications, failures, and market complaints.
- Identify the root cause and implement corrective and preventive actions.
- Process/Product Risk Evaluation:
- Evaluate process/product risks and recommend actions for proposed changes.
- Collaboration:
- Work closely with Production, Quality Assurance, Regulatory Affairs, Quality Control, and Supply Chain teams to gather data and reports for successful process transfer.
- Documentation and Report Preparation:
- Prepare and review various essential documents, including:
- Protocols and reports for confirmatory, submission, pre-validation, and process qualification batches.
- Master formula records, manufacturing instructions, packing instructions, process orders, and material reservations.
- Stability reports, license applications for technology transfer products, and SOP compliance documentation.
- Prepare and review various essential documents, including:
- Process Safety Management:
- Participate in process safety management activities, ensuring safety measures are followed during batch executions.
- Investigation of Ongoing Process Verification:
- Participate in ongoing process verification investigations to ensure product quality and compliance.
- Product Quality Review:
- Review Product Quality Reports (PQR) to ensure adherence to quality standards.
Additional Information:
- Qualification: M.Pharmacy / B.Pharmacy
- Location: Pydibimavaram (specific location within India)
- End Date for Application: 25th January 2025