Senior Executive Job in Cadila Pharmaceuticals Ltd at Dholka
FEATURED JOBSenior Executive
Cadila Pharmaceuticals Ltd
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Posted: 23 Jul 26
Job Description
• To ensure compliance of Validation, Qualification, Re-Qualification and Re-Validation activities as per schedule pertaining to Manufacturing facility at Dholka site in line with the cGMP requirements of national and international regulatory authorities.
• Planning and execution of Process Validation, Packing Validation, Transportation Validation and Cleaning Validation activities pertaining to Dholka site in line with the cGMP requirements of national and international regulatory authorities.
• To prepare, review and approve SOP’s., Validation & Qualification protocols and reports.
• To perform the validation exercises of new as well as existing equipment’s, utilities and critical systems.
• 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
- Process Validation of new product as well as existing products
- Hold Time Study
- Packing Validation, Transportation Validation of products
- Cleaning Validation
• Coordinate and participate in Aseptic Process Simulation (Media fill) Studies.
• To review and approve CAPA, Deviation & Change Control.
• To ensure smooth technology transfer of new product to plant level sign the Technical agreement with customer.
• To prepare and update Annual Validation Master Planner and Equipment Matrix of all Blocks.
• To ensure the implementation and maintenance of Current Good Manufacturing Practice (cGMP) standards and all such international quality standards.
• To ensure that the product meets the defined standards for strength, identity, safety, purity and quality by various system-driven approaches.
• To appoint the qualified staff for technical function and ensuring their technical and overall development through systematic training processes and reviewing their performance periodically.
• Ensure proper implementation of corporate policies / guidelines.
• To participate various regulatory / customer audits and ensure the compliances of Audit observation.
• To ensure cGMP related training program for all concerned manpower.
• Responsible to assist for handing of activities related to Vendor Approval.
• To Perform Vendor Audits for Vendor Qualification as per requirement of RM/PM.
• To prepare, review, execute and compile the protocol and report of Process Validation.
• To prepare, review, execute and compile the protocol and report of Hold Time Study.
• To prepare, review, execute and compile the protocol and report of Packing Validation.
• To prepare, review, execute and compile the protocol and report of Transportation Validation.
• To prepare, review, execute and compile the protocol and report of Cleaning Validation.
• Any other jobs assigned from time to time."
1. Planning and execution of Validation, Qualification, Re-Qualification and Re-Validation activities pertaining to Manufacturing facility at Dholka site in line with the cGMP requirements of national and international regulatory authorities.
2. To Perform Vendor Management Activity to assure that Vendors are Complying with Cadila SOP on Vendor Management and GMP Requirements in Order to source Quality Materials and Products.
3. To perform the validation exercises of new as well as existing equipment’s, utilities and critical systems.
4. Preparation, Execution, Compilation & Review of qualification and Validation Protocols & Reports.
5. Preparation of SOPs pertaining to qualification and Validation activities.
6. To prepare and update Annual Validation Master Planner and Equipment Matrix of all Blocks.
7. To prepare, review, execute and compile the protocol and report of Transportation Validation.
8. To Performed FAT(Factory Acceptance Test), SAT(Site Acceptance Test).
9. 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
10. To initiate and review change control, deviation and CAPA
11. To prepare, review protocol and reports and execute activity related to Aseptic Process Simulation (Media fill) Studies
12. Any other jobs assigned from time to time.
Job Particulars
Role head quality
Education Any Graduate
Who can apply Freshers
Hiring Process Face to Face Interview
Employment TypeFull Time
Job Id2928940
Job Category Quality Control
Locality Address
State Gujarat
Country India
About Company
Cadila Pharmaceuticals Ltd
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