07 Aug
|
BioMatrix Healthcare
|
Ahmedabad
07 Aug
BioMatrix Healthcare
Ahmedabad
Job Summary:
The Executive/Sr.
Executive Technology
Transfer will be responsible for executing technology transfer activities from R&D; to commercial manufacturing and between manufacturing sites. The role involves coordinating cross-functional teams, ensuring smooth scale-up, process validation, and compliance with cGMP and regulatory requirements for regulated and semi-regulated markets.
Key Responsibilities
Execute technology transfer activities for new product introductions and site transfers.
Prepare and review Technology Transfer Protocols (TTP), Technology Transfer Reports (TTR), Batch Manufacturing Records (BMR), and supporting documentation.
Coordinate with R&D;, Production, QA, QC, Engineering, Warehouse, and Regulatory Affairs for successful product transfer.
Participate in process scale-up, exhibit batches, engineering batches, process validation, and commercial batches.
Provide technical support during manufacturing and troubleshoot process-related issues.
Review manufacturing processes and recommend improvements for productivity and quality enhancement.
Ensure smooth transfer of products for Tablets, Capsules, Dry Powder, and Syrup dosage forms.
Prepare risk assessments, process flow diagrams,
and technology transfer documentation.
Monitor critical process parameters (CPPs) and critical quality attributes (CQAs) during transfer activities.
Ensure compliance with cGMP, GDP, Data Integrity, and company SOPs.
Support regulatory submissions by providing technical documentation and responding to queries.
Coordinate change control, deviation, CAPA, and investigation activities related to technology transfer.
Participate in qualification and validation activities, including Process Validation, Cleaning Validation, and Equipment Qualification.
Support internal, customer, and regulatory audits.
Required Skills
Robust knowledge of technology transfer processes in OSD manufacturing.
Experience with Tablets, Capsules, Dry Powder, and Syrup manufacturing.
Knowledge of cGMP, ICH Guidelines, QbD, Process Validation, and Data Integrity.
Experience in regulated markets such as EU, ROW, and Africa.
Positive documentation and technical writing skills.
Robust analytical, problem-solving, and coordination abilities.
Effective communication and cross-functional collaboration skills.
📌 Technology Transfer Ahmedabad
🏢 BioMatrix Healthcare
📍 Ahmedabad