Prepare, review and execute validation master plan for the plant validation & qualification protocols for all plant processes, facilities, utilities & equipment.
Product quality review trending and analysis
Continuous water monitoring on a quarterly basis.
Managing of validation documentation and completion of validation risk assessments
Preparation and Review of Departmental SOPs.
Work with QA, Production, Maintenance and other departments to resolve audit finding.
To participate in corporate, regulatory and internal audits as necessary
Focus on process, cleaning and product validation studies and maintain GMP compliance at all times
B. Pharm or B.sc in any applied Sciences (Biochemistry, microbiology, etc.)
Minimum 1 year experience in validation and qualification in a manufacturing company.
A working knowledge and practical experience with equipment qualification protocol and report compilation.
Knowledge of temperature/humidity mapping, data processing and reporting
A working knowledge of Microsoft office and statistical packages.
Excellent communication skills
Good organizational and planning skills.
Good written communication and report writing skills.
Good problem solving skills