About our client
Strides creates a work environment characterized by an open, entrepreneurial culture that fosters creativity and innovation. Within the rigor of an exciting and challenging industry, employees have an opportunity to work with partners in some of the world’s leading pharmaceutical companies, the best talent, and associate themselves with an organization that is recognized for path-breaking initiatives and adherence to the highest standards of ethics and integrity.
As multinational company, Strides is committed to a culture of diversity, reflected in a substantial and varied workforce across the globe. Employment decisions at Strides are based solely on merit, qualifications and abilities, ensuring a strict anti-discrimination policy based on gender, race, colour, nationality, sexual preference, marital status, age, disability, religion or employment status.
Strides recognizes the demands of the current work environment and importance of maintain a balance between personal and professional responsibilities and aspirations. To that end, their HR policies are designed to provide flexibility and help employees lead a more fulfilled life. Flexi time options, state of art gyms, a cricket club, runners club and artists groups are just some of the facilities available to all Stridians. The company also operates a "We Care" programme exclusively developed to address the wellness and health needs of employees through sessions conducted by doctors at Strides facilities.
Strides also has generous Rewards and Recognition Policies like the Leadership Incentive Compensation Plan, the Employee Stock Ownership Plan, the Long Service Award and Cash Award, all ensure that employees across all hierarchies within the company feel valued, motivated, and fulfilled by their work.
- Independently lead analytical method develop and validation activities for assigned ANDA products.
- Develop and validate analytical methods for release and stability testing.
- Review and evaluate drug substance supplier’s technical documents and provide recommendation in API vendor selection.
- Identify specification requirements and set up specifications and specification justifications for raw materials and drug products.
- Resolve complex problems in method or product development.
- Develop and understand product stability to guide design of stability studies in support of product registration.
- Generate technical documents to support regulatory submissions.
- Provide timely analytical support on deficiency responses and product approval inspections.
- Review laboratory notebooks, raw data and technical documentation in support of regulatory filings.
- Interact with other depts: Formulations, Regulatory Affairs, Production, Strategic Sourcing, etc., to support timely new product development/submission of new ANDAs.
- Peer review of lab notebooks.
- Evaluate, troubleshoot/improve existing analytical methods when necessary.
- Continuously update knowledge of latest technologies related to analytical science
- Work in compliance with cGMP/cGLP regulations.
- Strong knowledge of analytical chemistry and concepts in developing and validating methods to meet correct pharmaceutical standards.
- Superior knowledge of major analytical techniques such as HPLC/UPLC, dissolution, FT-IR, physical characterization, etc.
- Strong knowledge of FDA, ICH, and USP guidance and regulations.