Date PostedMarch 20, 2023
Location (State / UT)
Experience10 Years, 12 Years
Desired QualificationMaster’s Degree, Bachelor Degree
Roles and Responsibilities
- To have the knowledge & complete understanding of Quality Control functionality.
- To have hands-on experience in team handling and project management.
- To have an understanding of the dynamics of computerized systems wrt regulatory standards and functional requirements (21 CFR part 11, 210 & 211, GAMP, Eudralex, ICH Quality guidelines, etc).
- To identify the roadblocks and ensure the smooth execution of assigned projects.
- To support functional and project teams for timely execution and completion of assigned activities.
- To perform the assigned activities regarding functional designing, Masterdata preparation, SOP preparation, qualification execution, and testing as per the project requirements.
- To identify the actionable and accomplish the project milestone.
- To prepare and review SOPs, and qualification scripts, and ensure execution of qualification.
- To prepare, ensure and support database and design preparation as per compliance requirements and functional needs.
- To ensure techno-functional training/support for each site, whenever required.
- To support site SMEs for the Stabilization of projects.
- To conceptualize and frame a consolidated approach for newly identified techniques regarding quality system automation.
- To ensure customer support for technical discussion on project finalization.
- To execute and support automation projects or any other project initiated for simplification, harmonization, and productivity enhancement.
- To work in collaboration with IT, API, Operations, vendor, Site Quality, and different teams for identification of the right solution /tool/Vendor, to resolve the “Specific problem statement” and have the correct solution for the organization.
- To ensure the successful handover of projects to their respective functional team.
- Support sites during regulatory audits, and internal/external audit observations.
Qualification: B.Pharma, M.Pharma
Experience: 10-12 years