The Project Engineer (QA) serves as a liaison between Quality Assurance and Operations in a pharmaceutical manufacturing setting, focusing on maintaining compliance and driving continuous improvement in the production of creams, gels, ointments, lotions, and liquid topical products. This role leads quality investigations, oversees CAPA management, and collaborates across departments to ensure adherence to GMP standards.
Responsibilities
- Lead and coordinate quality investigations related to the manufacturing of topical pharmaceutical products, applying root cause analysis techniques such as 5 Whys, Ishikawa diagrams, and DMAIC.
- Develop, document, and implement CAPA plans in collaboration with cross-functional teams, ensuring effective execution and verification of corrective measures.
- Maintain and update GMP documentation within the Quality Management System, including investigation reports, risk assessments, and SOP revisions.
- Interact directly with manufacturing personnel on the production floor to conduct fact-finding, gather process data, and provide guidance on deviation prevention.
- Manage cross-departmental quality initiatives involving Manufacturing, QA, QC, and Engineering, ensuring alignment and transparent progress tracking.
Requirements
- Minimum of two years of experience in the pharmaceutical industry, with preference for roles in Quality Assurance, Quality Control, or manufacturing engineering.
- Proven experience in conducting quality investigations, managing CAPAs, handling deviations, and maintaining GMP documentation.
- Familiarity with Quality Management System software such as TrackWise, Veeva, ETQ, Comet, or equivalent platforms.
- Knowledge of semi-solid and liquid dosage form manufacturing processes, including mixing, homogenization, and filling operations.
- Strong technical writing skills with the ability to produce clear, accurate, and compliant quality records.
- Solid organizational and project management skills, with a demonstrated ability to coordinate cross-functional teams and meet deadlines.
Tech Stack
TrackWise, Veeva, ETQ, Comet, GMP documentation, 5 Whys, Ishikawa, DMAIC
Benefits
- Empowering work environment with high employee ratings for autonomy and goal setting, scoring 8.4 or above in monthly Pulse feedback.
- Hybrid work model allowing employees to collaborate with managers to define flexible work schedules and locations based on role and personal needs.
- Unlimited access to leading learning platforms such as Harvard Business Review, Coursera, Pluralsight, Udemy, Microsoft, AWS, and Google for professional development.
Work Arrangement
hybrid — Employees work with their managers to determine an arrangement that works best for their role and personal circumstances.
- Autonomy and goal setting are highly rated in employee feedback.
- Flexible working environment supports work-life balance.
- Strong commitment to continuous learning and professional development.
Additional Information
- This position is situated within the Creams & Liquids production environment.
- Cross-functional collaboration and transparency in investigation progress are core values of the organization.
- Free access to learning platforms includes Harvard Business Review, Coursera, Pluralsight, Udemy, Microsoft, AWS, Google, and other educational resources.
