Validation & QMS (Sr Executive) For Pharma Company in Bangalore

Roles and Responsibilities

Job Title: Validation & QMS (Sr Executive)

Designation: Sr. Executive

Reporting to: Manager

No. of Positions: 2

Division: Formulation

Department: Engineering & Maintenance

Job Location:Bangalore Location
Qualification: BTech/BE Mechanical

Years of Experience: 5 to 10 Years
Salary Range: 8 to 11 LPA

Contact person: Mr.Zabi Moghal
Mobile: 8105301588
Email: zabi@bvrpc.com

Job Responsibilities:

• Preparation and review of qualification protocols, Temperature mapping protocols, Layouts and Sop’s as per established Company procedures and cGMP requirements.
• Must having the experiences and understanding of cleanroom facility and requirement.
• Must have knowledge of computer system validation requirement and preparation and execution of protocol related to computerized system with relevant stakeholders.
• Execute / supervise with the help of contractors on daily basis for follow up and completion of Qualification, Re-qualification, thermal mapping, other engineering cGMP documentation activities and projects.
• Execute / supervise the engineering department online documentation all time with respect to Equipment, Qualification / Re-Qualification / Thermal Mapping/ Training / Re-Evaluation and Engineering Stores.
• Prepare all facility drawings and layouts as per Company standards and procedures.
• Execute / Coordinate / maintain Quality of engineering projects in line with the cGMP and organization requirements
• Execute with Quality Assurance department for preparation and implementation of engineering department SOPs/Formats/System Manual and other engineering documents
• Performs all work in compliance with regulatory standards including current Good Manufacturing Practices (cGMPs), Safe Work Practices (SWPs), and established Company policies and procedures.
• Works as a team member to achieve all outcomes and troubleshooting of qualification issues. Suggests remedial and corrective actions, as required.