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Sr. Executive


Visakhapatnam, AP 530003
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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.


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


+ 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.
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