No deviation is a provider of patient-centric solutions for the pharmaceutical industry, and we are currently seeking individuals who are passionate about joining our team. Our areas of expertise include engineering consultancy, Commissioning Qualification Validation (CQV), as well as Quality, Compliance, and Regulatory services.
We strongly uphold our core values of Empathy, Integrity, and Transparency, and we strive to create a collaborative, innovative, and inclusive work environment that fosters personal growth and development.
By joining our team, you will have the opportunity to make a meaningful impact in the pharmaceutical industry while advancing your career.
Scope and Responsibilities:
- Generate and/or review process design documents (P&IDs, PFDs, URS, data sheets etc.)
- Participate safety & design reviews (i.e. 3D model, HAZOP and DQ)
- Manage project and / or site change control
- Vendor management
- Participate Quality Risk Assessment
- Review and approve other technical documents, wherever applicable
- Reporting of status of the assigned project/task
- Execute and/or coordinate all field work, wherever applicable
- Execute and/or coordinate commissioning, qualification and validation activities
- Overall responsibility for HSE matters in appointed area
- Troubleshooting and resolution of process related issues
- Management of deficiencies and deviations
- Provide SME input wherever required
- Support SOP generation
- Coordinate with identified stakeholder
- Complete trainings in a timely manner
Qualifications:
- Minimum Degree in Engineering or Science Disciplines
- Minimum 3 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 automation knowledge, adequate knowledge in utility and HVAC
- Project management / coordination experience
- Proactive and self-motivated
- Adequate knowledge on cGMP and other regulatory requirements, guidelines and industry best practices
- 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
EA License No: 19C9587