06 Aug
|
BioMatrix Healthcare
|
Ahmedabad
06 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.
- Good documentation and technical writing skills.
- Strong analytical, problem-solving, and coordination abilities.
- Effective communication and cross-functional collaboration skills.
📌 Technology Transfer (Ahmedabad)
🏢 BioMatrix Healthcare
📍 Ahmedabad