Formulations Quality Assurance Executive

Job Highlights:

Experience 7-9 Years

Pharmaceuticals
Specialization:

Formulation

Must Have Skills:

Quality Management System, In Process Quality Assurance, Engineering
Assurance, Equipment Validation, Risk Assessments and Gap Assessments

Good to Have Skills:

Technology Transfer, Risk Vendor Qualification, Computer System Validation.

Preferred Candidates:

Knowledge in Quality Management System,
In Process Quality Assurance (Solid Orals/ Liquids/),
Engineering Assurance (Calibrations and Preventive Maintenance) ,
Equipment Validation (URS/IQ/OQ/PQ),
Risk Assessments and Gap Assessments and
Working in the cGMP pharmaceutical industry with exposure in Global regulatory
audits.

Roles and Responsibilities:

∙Responsible for handling of QMS software and hands on experience on the global software tools in
QMS.
∙Responsible for review and approve or reject the QMS documents as a Site QMS Co Ordinator.
∙Responsible for preparation and review the investigations and risk assessments and any Gap
Assessments and providing inputs.
∙Responsible for reviewing the documents, protocols, SOPs, and performing the GAP assessments
and harmonization of the procedures.
∙Conduct Internal audits.
∙Set Maintain and implement the quality metrics in close coordination with the CQA.
∙Preparation, and review of QMS trends and circulating the QMS activities for the CFT and working
with Collaboration with CFT Teams.
∙All time readiness at the site for the regulatory/ Customer inspections.
∙Responsible for the vendor qualifications of API/Raw Materials and Excipients and handling of
Vendor dossiers.
∙Responsible for the maintenance of approved documents and archival procedures as per 5S
standards with Document Co- Ordinator.
∙Responsible for the preparation and training of corporate polices and procedures.