Senior Quality Officer (Pharma-Injectable Plant Only)

Cadila Pharmaceuticals Limited; Udaipur District; On-site; INR 700,000 - 1,100,000; Full time

Job summary

Cadila Pharmaceuticals Limited in Udaipur is seeking a dedicated Validation Specialist to oversee validation, qualification and re-validation of manufacturing facility equipment and systems in line with cGMP.

You will coordinate with cross-functional teams, prepare protocols and master plans, manage vendor qualification and audits, and contribute to continuous improvement through CAPA and change controls.

Qualifications

• Responsible for validation, qualification and re-validation of equipment, utilities and critical systems.
• Manage vendor qualification and GMP compliance to source quality materials.
• Prepare, review and compile validation protocols and reports; update master plan and equipment matrix.

Responsibilities

• Perform validation exercises of new and existing equipment, utilities and critical systems.
• Prepare, execute and review qualification protocols and validation reports.
• Prepare SOPs for qualification and validation activities.
• Maintain Annual Validation Master Plan and Equipment Matrix.
• Coordinate with cross-functional teams for HVAC, utility and temperature mapping validations.
• Initiate and review change controls, deviations and CAPAs.
• Prepare and execute Aseptic Process Simulation (media fill) studies.
• Assist vendor approvals and manage vendor audits.
• Assist in preparing vendor lists and vendor grading based on supply performance.
• Any other related tasks as assigned.

Skills

Validation expertise

Vendor management

cGMP knowledge

Cross-functional coordination

Job description

Role & responsibilities

Major purpose of the job:

• Planning and execution of Validation, Qualification, Re-Qualification and Re-Validation activities pertaining to Manufacturing facility at Udaipur site in line with the cGMP requirements of national and international regulatory authorities.
• To Perform Vendor Management Activity to assure that Vendors Are Complying with CPL SOP on Vendor Management and GMP Requirements in Order to source Quality Materials and Products.

Principal Task and Responsibilities:

1. To perform the validation exercises of new as well as existing equipments, utilities and critical systems.
2. Preparation, Execution, Compilation & Review of qualification and Validation Protocols & Reports.
3. Preparation of SOPs pertaining to qualification and Validation activities.
4. To prepare and update Annual Validation Master Planner and Equipment Matrix of all Blocks.
5. To prepare, review, execute and compile the protocol and report of Transportation Validation.
6. Coordination with cross functional teams for smooth conduction of validation activities with respect to: ? Equipment Qualification / Re-Qualification, Validation / Re-Validation ? HVAC System Validation and Utility Validation ? Temperature Mapping Study of critical area
7. To initiate and review change control, deviation and CAPA
8. To prepare, review protocol and reports and execute activity related to Aseptic Process Simulation (Media fill) Studies
9. Responsible to assist for handing of activities related to Vendor Approval.
10. To Perform Vendor Audits for Vendor Qualification as per requirement of RM/PM.
11. To assist for preparation of Approve Vendor List of RM/PM and to assist for preparing Vendor Grading of RM/PM based on Rejection of Supply from Vendors on Yearly Basis.

Any other jobs assigned from time to time.

Preferred candidate profile

: Must be from Injectable