QC Specialist
About No deviation
At No deviation, we are dedicated to delivering patient-centric solutions that revolutionize the pharmaceutical landscape. As a dynamic expert in engineering consultancy, Commissioning Qualification Validation (CQV), and Quality, Compliance, and Regulatory services, we are looking for individuals who are excited to contribute to impactful projects and drive innovation.
We believe that great things happen when Empathy, Integrity, and Transparency guide our actions. That's why we foster a culture of collaboration, inclusion, and continuous development – empowering our team members to grow personally and professionally.
Position Overview
The QC Personnel will be responsible for supporting day-to-day Quality Control laboratory activities, including testing, documentation, method validation support, data review, and compliance with GMP requirements. The role requires hands-on experience with laboratory systems such as GLIMS, Veeva, and SAP, as well as experience in analytical method validation activities.
Key Responsibilities
- Perform routine QC testing for raw materials, intermediates, finished products, stability samples, and/or environmental monitoring samples, as applicable
- Execute laboratory testing in accordance with approved SOPs, test methods, specifications, and GMP requirements.
- Ensure all laboratory activities are completed accurately, timely, and in compliance with data integrity expectations.
- Support sample receipt, testing coordination, result entry, and laboratory documentation.
- Support analytical method validation, verification, transfer, and qualification activities.
- Execute validation protocols and document results in accordance with approved acceptance criteria.
- Assist in the preparation, review, and closure of method validation protocols, reports, deviations, and supporting documentation.
- Support troubleshooting of analytical methods and laboratory investigations where required.
- Use GLIMS for sample management, test assignment, result entry, and laboratory workflow tracking.
- Use Veeva for document management, SOP retrieval, document review, training, and quality records where applicable.
- Use SAP for material/sample-related transactions, inventory checks, batch information retrieval, or quality-related processes.
- Ensure proper documentation practices in line with ALCOA+ principles and GMP expectations.
- Support laboratory investigations, OOS/OOT investigations, deviations, CAPA, and change control activities.
- Ensure timely escalation of abnormal results, laboratory issues, equipment issues, or documentation discrepancies.
- Participate in internal audits, external inspections, and laboratory readiness activities.
- Maintain laboratory areas, equipment, reagents, standards, and records in an inspection-ready state
- Support calibration, maintenance, and qualification readiness of laboratory equipment.
- Assist in laboratory process improvements, system updates, and workflow optimization.
- Work closely with QA, Manufacturing, MSAT, Validation, and Supply Chain teams to support product release and compliance requirements.
Required Qualifications
- Diploma or Degree in Chemistry, Pharmaceutical Science, Biotechnology, Microbiology, Life Sciences, or related discipline.
- Minimum 2 to 5 years of QC laboratory experience in a pharmaceutical, biologics, medical device, or GMP-regulated environment.
- Experience with method validation, method verification, or method transfer is required.
- Hands-on experience with laboratory or quality systems such as GLIMS, Veeva, and SAP.
- Experience in QC testing, laboratory documentation, investigations, and GMP compliance.
- Familiar with GMP, GDP, data integrity, ALCOA+, and laboratory compliance requirements.
- Experience with analytical techniques such as HPLC, GC, UV, pH, conductivity, TOC, endotoxin, bioburden, sterility, or other QC methods will be advantageous.
- Able to execute and document method validation activities according to approved protocols.
- Comfortable working with electronic systems for sample tracking, document control, training, and material/batch-related transactions.
Why join us?
- Generous Leave Policy.
- Comprehensive Health & Wellness Coverage: Receive robust medical and dental coverage to support your health needs.
- Professional Development Opportunities: Access continuous learning programs and resources for career growth within the company.
- Inclusive Culture: Work in an environment where innovation, collaboration, and diverse perspectives are encouraged and celebrated.
- Shape the Future: Make a real difference in the pharmaceutical industry while advancing your career.
How to apply
Are you ready to play a key role in shaping the future of pharmaceutical solutions? If you're passionate about making an impact, we want you on our team!
Please submit your resume, outlining your qualifications and experience relevant to the role, here.