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:
- Function as a Subject Matter Expert (SME) for CSV topics.
- Develop and implement validation plans and protocols for CSV projects (DeltaV).
- Responsible to analyze, identify and resolve issues that potentially impact validated status of Computer systems.
- Report to the Quality Engineering Manager, as part of the Quality Organization.
- As the Subject Matter Expert (SME) in CSV topics, provide guidance and support to establish systems for ensuring Data integrity, compliance to CSV Plan and 21CFR Part 11.
- Establish CSV project plans and execution plans for GMP computer systems like DCS, PLC, BMS, MES, and eBR.
- Generate, review and execute protocols related to project(s).
- Work with teams that provide Quality Assurance oversight to ensure compliance to cGMP standards and company policies and procedures.
- Maintain records to comply with Good Manufacturing Practice requirements.
- Assist in the review and assessment of Change Requests and responses to CAPAs, particularly related to project for GMP computer systems.
- Any other duties as assigned by your Supervisor/Manager.
Qualifications:
- Bachelor's degree or a diploma of technical specialization like Engineering/Pharmacy
- 5 years of relevant work experience
- Hands-on experience in the Validation life cycle of computer systems (DeltaV) is a must
- Experience in CSV activities in brownfield projects or operations support is a plus
- Good leadership and communication skills
- Mentoring and coaching skills
- Excellent team player willing to work for the common goal
