AGM_Analytical Method Validation_Pharma_15 to 20 Years

Pharma analytical development, product specifications, method validation, method transfer, stability evaluation, comparability studies, thorough with GMP and GLP, team and laboratory management, semi-solid formulations, USFDA ANDA filing desirable.

Mandatory experience:

- Process work within Pharmaceutical manufacturing

- Commissioning and Qualification management and execution for complex pharmaceutical manufacturing equipment

- Risk Assessment for pharmaceutical production (CQA, CPP, SIA and Control strategy)

- Validation Management for Process Validation

- GAMP5-experience

Job Description:-

1. Provide support and guidance to the team for new method development and troubleshooting for method development.

2. Expertise in - Analytical method development of Assay, Related Substances & Dissolution Method of various drug products by HPLC as per ICH Q2 requirements.

3. Preparing and review analytical method development and analytical investigation reports.

4. Analytical support and analytical problem solving to facilitate product development activities, including accelerated and long term stability testing and process development.

5. Transferring new analytical techniques to the Quality Control.

6. Purchasing, validating and maintaining equipment for analytical development activities.

7. Development of cleaning method for drug products.

8. Controlling laboratory chemicals required for analytical development activities.

9. Review the data of calibration.

10. Preparation SOPs as when required, and prepared tentative Spec /STPs of during development.

11. Participating in self-inspections and regulatory inspections.

12. Supervising, motivating, coaching and mentoring the analytical development team.

13. Ensuring good relations and communications with all members of the team and responding politely and in a timely fashion to internal and external customers.

14. Observing and complying with Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP).

Desired Candidate Profile :

1. Quality control Management

2. Finished Products

3. Raw Material

4. Method Validation

5. Quality Improvement

6. Quality Assurance

7. Quality Control Tools

8. Quality Check

9. Product Quality

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