Agm/dgm- Adl - Haridwar, India - Nisvan HR Solution Pvt Ltd

Nisvan HR Solution Pvt Ltd
Nisvan HR Solution Pvt Ltd
Verified Company
Haridwar, India

1 week ago

Deepika Kaur

Posted by:

Deepika Kaur

beBee Recuiter


Description

Position:
AGM/DGM (ADL)

  • Injectable and OSDs
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Market: Domestic & Semi Regulated

-
Experience required: 15-20 Years

-
Qualification: M Pharma (Pharmaceutical Chemistry/Analytical Research)

  • Desirable, PhD

Responsibilities:


Leading and managing a team of analytical scientists (15+): Overseeing their work, providing guidance and ensuring effective collaboration within team.


Developing analytical strategies, method development:
Designing and implementing analytical methods and techniques to support drug development and quality control processes. Expertise in designing and developing robust and reliable analytical methods for various types of drug substances and drug products. This includes methods for assay, impurity profiling, dissolution testing and stability indicating methods.


Validation and method transfer:

Good understanding of method validation guidelines (e.g., ICH guidelines) and the ability to validate analytical methods for accuracy, precision, specificity, linearity, and robustness.

Expertise in method transfer between laboratories and multiple sites is a must have.


Quality by Design (QbD): Knowledge of QbD principles (good to have) to develop methods that are designed for reliability, robustness, and compliance with regulatory expectations.


Analytical method verification and validation:
Ensure that all analytical methods used in R&D are validated, verified, and comply with regulatory guidelines


Quality control and assurance:
Monitoring and maintaining high standards of analytical data integrity and accuracy to ensure compliance with regulations and internal quality standards


Instrumentation and equipment management:
Overseeing the selection, qualification and maintenance of analytical equipment and instruments


Data analysis, interpretation and troubleshooting:
Reviewing and interpreting analytical data to provide valuable insights to the R&D team and management.


Continuous improvement:
Identifying opportunities to enhance the efficiency and effectiveness of analytical processes and implementing best practices.


Budget, hiring and resource management:
Managing the analytical department's budget, staffing, and resources effectively.


Training and development:
Providing training and mentoring to the analytical team to enhance their skills and knowledge.


Salary:
₹80, ₹100,000.00 per month


Schedule:

  • Day shift

Ability to commute/relocate:

  • Haridwar, Uttarakhand: Reliably commute or planning to relocate before starting work (required)

Experience:


  • ADL: 10 years (required)

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