At No deviation, we strive to deliver our best every day. We apply our core values of empathy, integrity and transparency to every activity, including engagement with our employees. If you are ready to take on the challenges of a dynamic business, please follow the link below to explore the job opportunities that await you. We look forward to speaking with you.
· Responsible for preparing and executing test documentation for GMP computerized systems as well as providing support in the troubleshooting of issues during test execution. You should have excellent understanding of 21 CFR Part 11, ICH standards, EMA and FDA (GxP) regulations, and GAMP methodologies.
· Coordinate with multi-disciplinary validation team and be responsible for the validation of automated equipment and control systems
· Create and modify validation documentation including but not limited to:
- User Requirements Specifications (URS)
- Design Reviews (DR)
- Criticality assessments
- CSV protocols (SAT, IQ, OQ, PQ) which verify if the system is compliant to regulatory and client requirements
- Reports which summarize the results of the protocol executions
- Exception reports which identify defects or issues during test execution
- Review vendor documentation
· Continuous improvement on validation process and procedure
· Assist or coordinate generation of Standard Operating Procedures (SOPs)
· Follow the proper site safety practices; wearing adequate safety equipment when required
· Degree in Engineering or Science discipline. Preferably in Electrical Engineering, Computer Science/Information Technology, or Chemical/Biochemical/Mechanical Engineering.
· Minimum 3 years of experience in Pharmaceutical Industry
· Proven track record in promoting safety practices in related role
· Demonstrated proficiency of written and verbal communication skills (including technical writing and presentations) with ability to communicate and collaborate effectively with technical and senior management staff
· Proactive, self-starter and capable of working alone or in a team environment.
· Familiar with Microsoft office suite of applications
· Ability to interpret and operate within defined schedules managing available resources to achieve project milestones
· Previous DCS (DeltaV), WinCC, SIEMENS and Rockwell automation systems testing experience required
· Experienced in developing automation protocols
· Good knowledge of cGMP, GAMP, GDP, 21CFR Part 11 and ICH Q10 guidelines
· Knowledge of ASTM 2500E risk-based approaches
· To be aware and supportive of the project’s requirement for flexibility in working hours/shift patterns through the differing phases of the project’s life cycle
· Experience with Quality Change Control is desirable
- Generate/review/execute CQV (Commissioning/ IQ/OQ/PQ/PPQ) protocols
- Perform data analysis to evaluate process capability and make recommendations for process improvement where necessary
- Manage or coordinate Change Controls
- Review and approval of CQV & Technical documentation
- Develop or participate in risk assessments associated with CQV activities, Change Controls or CAPAs.
- Review test documents relating to CQV activities, Change Controls and CAPAs.
- Ensure equipment systems and processes are appropriately validated in line with approved procedures, protocols and schedules.
- Assist with the review and enhancement of existing validation documentation, where appropriate.
- Lead a team to complete assigned tasks on time, on budget and safely while adhering to quality and engineering standards
- Vendor management
- Provide input on project schedule, coordinate project and/or site activities
- Tracking and reporting of project status, including cost status.
- Lead and coordinate all field work.
- Overall responsibility for HSE matters in appointed area
- Troubleshooting and resolution of Process or System related issues
- Management or coordination of deficiencies and deviations
- Ensure smooth hand-over to end user
- Resource planning for assigned areas
- Coordinate with other functions / teams
- Degree in Engineering or Science Disciplines
- Minimum 5 years’ experience in a related field/Pharmaceutical Industry
- Proven track record in following and promoting Safety in all aspects of your role
- Strong process and CQV knowledge, adequate knowledge in automation, utility and HVAC.
- Project management/coordination experience
- Proactive and self-motivated
- In-depth knowledge on cGMP, GDP and ASTM E2500 approaches to C&Q.
- Be IT literate and familiar with Microsoft office suite of applications
- Demonstrated proficiency of written and verbal communication skills in English (including technical writing and presentations) with ability to communicate and collaborate effectively with technical and senior management staff
Contact us for details
Contact us for details
Contact us for details