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Sr. Executive

Pfizer


Location:
Visakhapatnam, AP 530003
Date:
01/23/2018
2018-01-232018-02-23
Pfizer
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Job Details

**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.



**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







Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
Apply on the Company Site
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