Work as Validation Engineer at Pfizer | B.Pharm, M.Pharm, M.Sc

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 : Validation Engineer (Executive)- Execution

Job Description
• Execute Validation of manufacturing equipment, visual inspection equipment ,packing equipment, Utilities, LAB equipment, Cleaning Validation and Process Validation in accordance with regulatory requirements, cGMPs, corporate policies and procedures and as per schedule
• Operation and Calibration of KAYE Validators and validation Accessories
• Knowledge on the Qualification lifecycle for the manufacturing, Lab and packing equipment.
• Knowledge on the preparation and Review of qualification protocols.
• Knowledge on sampling techniques
• Coordinate and plan Validation activities with Manufacturing, QC, Microbiology and Projects
• Performs Data analysis, Investigation of Validation deviations for the root cause identification.
• Compile validation documents and results
• Execution/ oversite of executions and reporting of deviations.
• Assisting to Reporting during Validation planning and execution.
• Perform Risk assessment to establish the scope and extent of Validation activities
• Adherence to Safety Procedures/GMP & GDP Practices

Candidate Profile
• B.Pharm/ M.Pharm/M.S (Pharmacy)/M.Sc/ BE
• 2+ years’ Experience in validation / QA function of sterile dosage form facility
• Understanding of pharmaceutical manufacturing, packaging, quality assurance, and quality control operations
• Knowledge of validation principles and practices related to the following areas: manufacturing process, analytical method, cleaning methods, facility, equipment, instrument, utility system, and CSV systems
• Conversant with design & working principles of key equipment used in sterile manufacturing –autoclave, tunnel, lyophilizers, homogenisers, filling machine, filter integrity testing devices
• Well versed with Terminal process – design, execution and review
• Experience in plant and QC lab operations
• Good document written skills, with ability to identify issues and recommend actions
• Knowledge of current Validation regulations in the industry
• cGMPs and FDA , MHRA, TGA, MCC etc. regulatory guidelines and Validation principles
• Strong Technical, organizational planning and project management skills, in addition to strong technical background required to coordinate multi-disciplinary teams
• Excellent interpersonal effectiveness and communication skills (written and oral) to interface across departments and management levels

Additional Information
Qualification : B.Pharm, M.Pharm, M.Sc, B.E
Location : Vizag
Industry Type : Pharma/ Healthcare/ Clinical research
End Date : 20th November, 2019