JOB DESCRIPTION
Coordinate cleaning validation activities for API manufacturing Pharmaceutical plant. Prepare and execute protocols and reports for cleaning development and validation. Perform investigation of deviations / discrepancies. Oversees and reviews validation area processes.
The responsibilities may include some or all of the following.
Monitoring and testing:
- testing the proper functioning of utilities & equipments and resolving any issues, including making adjustments or improvements;
- maintaining the correct calibration and other parameters of instrumentation and equipment;
- correctly interpreting customer requirements, and initiating and supervising validation activities.
Reporting and documentation:
- creating databases and validation schedules to track validation activities;
- documenting test results and performing analyses;
- preparing compliance, analysis and other reports.
Training and supervision:
- training and updating staff in your team;
- overseeing the work of junior team members;
- regularly updating knowledge of industry standards and regulations.
QUALIFICATIONS
- Bachelor's or Master's Degree in Science, Pharmacy or Engineering.
- Minimum of 2 to 5 years of professional experiences in cleaning validation in the pharmaceutical and biotechnology industries.
Specific skills and attributes you will need typically include:
- Detailed understanding of manufacturing processes and the appropriate safety regulations.
- Knowledge of statistical software analysis using systems such as MATLAB.
- Ability to find effective solutions to complex problems using analytical thinking and a methodical approach.
- Excellent mathematical skills and attention to detail.
- Good organisation and time management.
- Proficient knowledge of validation, continuous process improvement and troubleshooting processes.
- Strong project management & organization skills.
- Proven leadership & teamwork skills, self-starter, results oriented and build and maintain strong relationships with multiple groups.
- Proficient in Risk Assessment/Management
- Proven assessment, analytical and problem-solving skills.
- Proficient presentation skills and Technical Writing/Oral communication skills (English)
- Proficient in cGMP's, OSHA and FDA Regulations as it applies to pharmaceutical industry.
