Description
Use Your Power for Purpose
Every day, our unwavering commitment to quality ensures the delivery of safe and effective products to patients. Our flexible, innovative, and customer-oriented culture is rooted in science and risk-based compliance. Whether you are engaged in development, maintenance, compliance, or research analysis, your contributions have a direct impact on patient care. By being part of our team, you help uphold a quality culture that adapts and evolves to meet the needs of patients, ensuring that every product we deliver meets the highest standards of safety and efficacy.
What You Will Achieve
In this role, you will:
- Perform method transfers, validations, and verifications for complex analytical techniques.
- Interpret and evaluate data for accuracy, precision, trends, and potential cGMP impact, recommending corrective actions.
- Ensure all documentation and quality records comply with Good Manufacturing Practices and Good Laboratory Practices.
- Review and revise Standard Operating Procedures, analytical methods, and related documents.
- Conduct analyses on finished products, raw materials, and components.
- Contribute to complex projects, manage time effectively, and develop work activity plans.
Here Is What You Need (Minimum Requirements)
- Master's degree in Chemistry or Pharmacy with 8-10 years of experience in Analytical Method Transfer/Validation.
- Qualified in multiple analytical techniques, including HPLC, GC, IC, ICP-MS, Potentiometry, UV-Vis, FTIR, Karl Fischer, and pH meters.
- Demonstrated technical skills in method validation and testing.
- Ability to read and understand compendial methods, Standard Operating Procedures, and governmental regulations.
- Conduct analytical method validation according to ICH Q2 (R1/R2), USP, and EP standards.
- Handle OOS and OOT through QMS.
- Perform identification, assay, purity, and related analytical tests.
- Monitor critical process parameters and critical quality attributes.
- Support process validation and troubleshooting activities.
- Manage working standards and handle change control activities.
- Knowledge of Good Manufacturing Practices.
- Excellent organizational and communication skills.
Bonus Points If You Have (Preferred Requirements)
- Experience with laboratory work, particularly using analytical HPLC, GC, IC, ICP-MS techniques.
- Proven track record in leading continuous improvement projects.
- Strong knowledge of lean manufacturing principles, six sigma methodologies, and statistical analysis.
- Strong problem-solving skills and attention to detail.
- Ability to manage multiple priorities and meet deadlines.
- Excellent interpersonal skills and adaptability.