- Work on validating the design, implementation, and documentation of validation for manufacturing equipment, utility systems, facilities, manufacturing processes and computer/ information/ automation validation.
- Involve in writing and drafting new SOPs & training users on SOPs for various systems. Writing and execution of cleaning verification protocol and interim reports.
- Work with CIP, COP sytems. Set up the acceptance criteria for active ingredients and cleaning agent.
- Work on deviation and risk assessment writing.
- Perform swab/rinse sampling for active ingredients and detergent. Swab/Rodac sampling for microbiological contamination testing.
- Prepare worksheet based on existing SOPs for the cleaning method of the manufacturing and packaging equipment and executes it to identify the critical parameters during cleaning procedure. Perform feasibility and DOE studies for cleaning procedures.
- Generate the status reports and metrics by using the integrated track wise system along with crystal reports and their development processes.
- Prepare and update existing SOP for cleaning to make it more efficient and compliant based rules.
- Review and develop user requirement specification (URS), functional requirement specifications (FRS) and design specifications (DS) in compliance and conformance with FDA rules and regulation.
- Develop the validation protocols, executing tests, and construction of summary reports for IQs, OQs and PQs.
- Configure the changes including updates to global change control process.
- Perform computerized system validation project in compliance with cGMP, 21 CFR Part 11, Annex 11 and Data Integrity Plan and establish technical communications, document flow, testing requirements and resources necessary to complete the validation of a system.
Requires minimum a bachelor’s degree in biomedical engineering, bio technology or any related field.
Send resume to Dataquad Inc., 2000 S. Dairy Ashford Road, Suite 405, Houston, TX 77077