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.
We are seeking an experienced Senior QC Chemist to join our quality control team on a 1-year contract. The ideal candidate will have a minimum of 6 years of experience in quality control within the pharmaceutical or biopharmaceutical industry. This role requires advanced expertise in analytical methods, strong problem-solving skills, and an ability to work independently while collaborating closely with cross-functional teams.
Key Responsibilities
- Analytical Testing: Perform analytical testing on raw materials, in-process materials, and finished products in line with established protocols and cGMP standards. Utilize advanced techniques such as HPLC, GC, UV-Vis, and FTIR to ensure product quality.
- Data Review and Reporting: Analyze test results, compile comprehensive reports, and ensure accurate documentation of data in compliance with regulatory requirements. Conduct peer reviews of laboratory results generated by junior chemists.
- Troubleshooting and Process Improvement: Identify and troubleshoot analytical challenges and equipment issues, implementing corrective actions where necessary. Participate in continuous improvement initiatives to enhance testing processes and efficiencies.
- Compliance and Audit Preparation: Ensure adherence to SOPs, GLP, and cGMP regulations. Support internal and external audits by preparing documentation and providing subject matter expertise in QC processes.
- Method Development and Validation: Lead efforts in developing and validating analytical methods as required, ensuring they meet industry standards and regulatory guidelines.
- Training and Mentorship: Provide guidance and training to junior QC Chemists, promoting best practices in quality control and laboratory safety.
Requirements
- Education: Bachelor's degree in Chemistry, Biochemistry, or a related field. A master's degree is a plus.
- Experience: Minimum of 6 years in a QC role within a regulated environment, preferably in the pharmaceutical or biopharmaceutical industry.
- Technical Skills: Proficiency in advanced analytical techniques and experience with laboratory information management systems (LIMS).
- Regulatory Knowledge: Strong understanding of regulatory standards, including cGMP, GLP, and ICH guidelines.
- Attention to Detail: High level of accuracy and attention to detail, with strong organizational and documentation skills.
- Contract Duration: 1 year (with possibility of extension based on project needs and performance)
