Pfizer is the world's premier biopharmaceutical company taking new approaches to better health. We discover, develop, manufacture and deliver quality, safe and effective prescription medicines to treat and help prevent disease for both people and animals. We also partner with healthcare providers, governments and local communities around the world to expand access to our medicines and to provide better quality health care and health system support. At Pfizer, colleagues in more than 90 countries work every day to help people stay happier and healthier longer and to reduce the human and economic burden of disease worldwide.
Post : Sr.Executive (Validation specialist)- Validations
Technical Skills
- Understanding of pharmaceutical Utilities Validation, Periodic Re-Qualification, quality assurance, and quality control operations
- Knowledge of validation and Periodic Re-Qualification principles and practices related to the following areas: manufacturing process equipment, Utilities , Lab equipment, facility, equipment, instrument, utility system, and CSV systems
- Conversant with design & working principles of key equipment used in sterile manufacturing Equipment validations, utilities validations and Periodic Re qualifications.
- Well versed with process Equipment, Utility – design, execution and review.
- Experience in plant and QC lab operations
- Good document review skills, with ability to identify issues and recommend actions
- Knowledge on the Periodic Requalification, Periodic Review and Utilities qualifications sampling plans and Sampling Tools.
- Knowledge on the Pure Steam Quality Test kit operation.
- Good knowledge on the Utility Qualification samples evaluation.
- Knowledge on the process Capability verification for Critical process Parameters and Critical Quality attributes.
- Knowledge on the assessment of the Change controls and failure investigations.
Responsibilities
• Execute project and routine validations and compile results
• Execute validation of manufacturing equipment, Utilities , Periodic Requalification , Visual inspection equipment and packing equipment in accordance with regulatory requirements, cGMPs, corporate policies and procedures and as per schedule
• Operation and Calibration of Validation Instruments and Accessories
• Coordinate and plan validation activities with Manufacturing, QC, Microbiology and Projects
• Compile validation documents and results
• Ensure revalidations are performed within the established intervals.
• Knowledge on the Equipment Periodic Requalification and Utility Qualifications.
• Writing and review of SOPs pertaining to Equipment and Utilities operation, cleaning and maintenance; Provide feedback if need be
• Develop Periodic Re-qualification frequencies based on the QRM.
• Knowledge on the Validation concepts and ability to train the people.
• Preparation of the traceability matrix.
• Review of DQ, FAT/SAT activities/documents
• Participation and review of IQ/OQ/PQ/PR/PRQ protocols and Reports
• Review and investigation of qualification deviations
Additional Information:
Experience: 6+ Years
Location: Vizag
Education: B.Pharm/ M.Pharm/M.S (Pharmacy)/M.Sc
Industry Type: Pharma/ Healthcare/ Clinical research
Functional Area: Validation specialist
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