Division

Manufacturing

Department

Manufacturing

Employment Type

Permanent

Job Purpose

Monitor and control the manufacturing excellence activities by studying variability in production and passing benchmarks in quality for an API unit to reduce the variability so that best yield and quality is achieved

Accountabilities

• Knowledge on API Particle Size Reduction and capability to achieve the required PSD for various applications of dosage forms.

• To develop and implement the techniques to get desired Particle Size in API Manufacturing.

• Co-ordination with API Manufacturing Team to identify and resolve the PSD issues.

• Should be familiar with different techniques of API Crystallisation to achieve the PSD.

• Know How experience with Polymorphism of APIs.

• Experience & technique to achieve stringent / window particle size of APIs.

• Knowledge of Particle Size Instruments like Malvern, Sympatec etc.

• Awareness of selecting the accurate equipment or up-gradation of existing machines for robust & cost effective Micronization process.

• Capability to manage troubleshooting of milling operations like Jet-mill, Cad-mill, Multi-mill etc.

• Evaluation of crystallization process in R&D and its implementation in API manufacturing.

• Proactive involvement to identify the areas of concern and take initiative to achieve particle size.

• Coordinating with manufacturer / supplier for conducting milling trials with advanced market technologies.

• Ensure the sustainability of Particle Size improvement projects through close monitoring of key process parameters during and post implementation of project.

• Knowledge of cGMP standards and current regulatory requirement for APIs.

• Should have knowledge of Safety Procedure, FMECA, HIRA, HAZOP etc.

• Awareness of Powder Safety.

• Experience wrt Technology transfer

• Product scale-up

Education Qualification

B. E. (Chemical)

Relevant Work Experience

\xc2\xa2 10 years of experience in API Manufacturing with 2 years of experience in manufacturing excellence\xc2\xa2 Understanding of API manufacturing operations, safety & cGMP systems

Competencies/Skills

Collaborate to Succeed
Innovate to Excel
Perform with Accountability
Lead with Empathy
Act with Agility
Strong Domain Knowledge
People Management

Job Location

Patalganga

Shift Hours