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 & Responsibilities:
- Ensure all activities in compliance with cGxP, incl. data integrity
- Review and approval of analytical data / tests (analytical release)
- Oversight of all production and testing activities, ensures compliance with cGxP, incl. data integrity and eCompliance
- Support exception investigations
- Review and approval of production, QC, and AS & T records
- MBR review
- Support OpEx improvement projects
- Executes batch release in compliance with registration (if Qualified Person)
- Comply with all HSE guidelines
- Detect and report potential accident, risks and propose solutions
- Participate in HSE risk assessments
- Preparation and participation to internal HSE audits
- Responsible for participating in initial training and retraining
Qualifications:
- Several years of experience in pharmaceutical quality control, quality assurance or production
- Experience in Operations Management and Execution; Functional Breadth; Collaborating across boundaries; Applied Practice
- University degree with a scientific / technological background (e.g. Chemistry, Pharmacy, Biology, Biochemistry, or equivalent)
- Good (oral and written) in English; fluent in local language (oral and written)
- Collaboration- & result-oriented
- Good knowledge of GMP; Continuous Learning; Operational Excellence; Digital & Tech Savvy
- MS Office applications and other standard IT applications supporting Quality activities
- Technological competence; Quality Assurance; Knowledge of GMP, Quality Standards; Quality Control (QC) Testing
