Manisha Nikam

Led Project on use of AI in Annual Product Review. Led OPEX Project on Product Quality Review Process Improvement. Transfer and Integration of Annual Product Quality Reviews from inhouse and third party sites. Maintenance of Quality Management System includes risk assessment site audits deviation change control SOP and APQR approval. Maintenance of PQR Center Quality Handbook. Maintenance of Intra Company Agreement.

Led a Team of 25 professional employees. Implementation of GLORYA EDMS Database for PQR and SOPs. Managed QA documentation and Compliance activities across multiple Product Lines. Played a key role in Corporate Quality Initiatives and system transitions. Participated in Global, Customer, Site Quality Council. Hiring the new Head Count, responsible for Employee performance.. Support liasing Global third party contract manufacturer for PQR compilation. Implementation of Trackwise for QMS Management.

Continued QA responsibilities with a focus on compliance and documentation in a well-established pharmaceutical setup. Participated in Site Quality Risk Assessment.

Worked in a newly commissioned plant with exposure to cleaning validation and equipment qualification. Successfully faced audits by USFDA and WHO. Implementation of SHAPE, an ERP System in QC Specification Laboratory samples and Analysis.

Played a key role in establishing and implementing Quality Systems for a newly set-up capsule manufacturing facility. Contributed to the development of QA infrastructure and documentation.

Worked in the Quality Assurance department, primarily handling In-Process Quality Assurance (IPQA) for liquid oral and capsule inhaler formulations. Successfully faced regulatory audits by MCA South Africa and TGA Australia