Pfizer
All over the world, Pfizer colleagues work together to positively impact health for everyone, everywhere. Our colleagues have the opportunity to grow and develop a career that offers both individual and company success; be part of an ownership culture that values diversity and where all colleagues are energized and engaged; and the ability to impact the health and lives of millions of people. Pfizer, a global leader in the bio pharmaceutical industry, is continuously seeking top talent who are inspired by our purpose to innovate to bring therapies to patients that significantly improve their lives.
Job Title: Sr. Executive
Job Description:
Responsibilities:
- Execute project and routine validations and compile results
- Execute validation of manufacturing equipment, 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 Terminal sterilization and fill finish line qualifications.
- Writing and review of SOPs pertaining to Equipment operation, cleaning and maintenance; Provide feedback if need be
- Develop facility qualification reports
- 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 protocols and Reports
- Review and investigation of qualification deviations
- Assist / Deputy Manager/ Manger – Validation in performing the following
- Perform Risk assessment to establish the scope and extent of validation activities
- Prepare and review impact assessment documents
Others
- Number of Equipment/Instruments in coordinating with user departments
- Number of Qualification Documents.
- Adherence to Safety Procedures/GMP & GDP Practices
Qualifications:
Preferred Qualification: B.Pharm/ M.Pharm/M.S (Pharmacy)/M.Sc.
Target years of experience: 6+ years’ Experience in validation function of sterile dosage form facility.
Technical Skills:
- 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, isolators, filter integrity testing devices
- Well versed with Terminal process – 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 Qualification instruments and Tools.
- Knowledge on the Components level assessment, PM requirement.
- Good knowledge on the Validation instruments calibration
- Knowledge on the assessment of the Change controls and failure investigations.
Respected Sir ,
I Durgesh Mishra i have done my Msc Microbiology I am interested work do with you