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Executive (Validation Engineer)

Pfizer


Location:
Visakhapatnam, AP 530003
Date:
11/17/2017
2017-11-172017-12-18
Pfizer
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Job Details

**Preferred Qualification**



B.Pharm/ M.Pharm/M.S (Pharmacy)/M.Sc/ BE/ B tech.



**Target years of experience**



2+ years' Experience in validation / QA 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, filling machine, DCS and Lab equipment like HPLC,GC etc.



+ Knowledge on Terminal sterilization process - execution and review of computerized systems protocols.



+ Knowledge on IT infrastructures



+ Experience in plant and QC lab operations



+ Good document written skills, with ability to identify issues and recommend actions



+ Knowledge on Data Integrity and ALCOA principles







**Standards, Processes & Policies**







+ Knowledge of current validation regulations in the industry



+ cGMPs and FDA , MHRA, TGA, MCC etc. regulatory guidelines and validation principles







**Behavioral/Any Other Skills**







+ Organizational planning technical background required to coordinate multi-disciplinary teams



+ Excellent interpersonal effectiveness and communication skills (written and oral) to interface across departments and management levels







**Responsibilities**



Execute project and routine validations and compile results







+ Execute Computer system validation of manufacturing equipment, visual inspection equipment and packing equipment in accordance with regulatory requirements, cGMPs, corporate policies and procedures and as per schedule



+ Ensure Operation and Calibration requirements for Lab Equipment.



+ Qualification of Computerised systems and Lab equipment as per validation life cycle.



+ Coordinate and plan validation activities with Manufacturing, IT, QC, Microbiology and Projects



+ Compile validation documents and results



+ Prepare impact assessment documents



+ Writing of qualification Protocols and Reports.



+ Execution/ oversite of executions and reporting of deviations.



+ Execution of Spreadsheet qualification protocols







Assist to reporting Manger - Validation in performing the following







+ Perform Risk assessment to establish the scope and extent of validation activities







Others







+ 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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