Head - Manufacturing & Process Excellence - IT

Head - Manufacturing & Process Excellence - IT

Key Responsibilities :

- Spearhead all IT and BPE initiatives in the area of Manufacturing and Quality - MES, LIMS, LMS, Track & Trace etc. Work actively with all process owners to perform analysis and design of all new requirements to the existing systems, look constantly for improvement opportunities for benefit realization

- Conceptualize all Process Excellence and IT initiatives in the areas of Manufacturing, QA and QC to improve data integrity and compliance

- Constantly looks for process and productivity improvement opportunities in the area of manufacturing & quality, implement, manage change and ensure benefit realization

- Ensure all the systems are implemented according to the CGMP, GXP, QMS, global quality standards and in compliance with regulations

- Implement data security, backup procedures to ensure integrity of all data in systems

- Participate/lead investigations of any non-compliances observed in internal/extern audits of IT systems and put in appropriate CAPA and ensure closure

Qualifications & experience :

- Graduate/Post graduate qualification in pharmaceutical science/engineering with MBA from a premier institute with 15-20 years experience

- Experience in pharmaceutical manufacturing and quality operations.

- Exposure to quality process excellence tools and practices - Six Sigma, QBD, SPC, etc

- Expert on GMP, QMS, Validation and Regulatory expectations.

- Knowledge and experience of GXP systems audit

- Good people, planning, organizational and time management skills.

- Experience in managing large Global Programs involving cross-functional teams

Technical Skills :

- Exposure to chromatography systems like Empower, Chromoleon

- Exposure / working knowledge of MES, LIMS and QMS systems