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Senior Executive (Validation Specialist)

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



**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, CSV systems, DCS and Lab equipment like HPLC,GC etc



+ 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 of computerized systems.



+ Experience in plant and QC lab operations



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



+ Knowledge on the GAMP requirements.



+ Knowledge on the Components level assessment, PM requirement.



+ Knowledge on the assessment of the Change controls and failure investigations.



+ Knowledge on Data Integrity and ALCOA principles







**Standards, Processes & Policies**







+ Knowledge of current validation regulations in the industry



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







**Behavioral/**



**Any Other Skills**







+ Leadership, organizational planning and project management skills, in addition to 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 validation of Computerized systems for manufacturing equipment, Visual inspection equipment , packing equipment and Lab Equipment validations in accordance with regulatory requirements, cGMPs, corporate policies and procedures



+ Operation and Calibration of Validation Instruments and Accessories



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



+ Compile validation documents and results



+ Ensure revalidations are performed within the established intervals for CSV systems.



+ Writing and review of SOPs pertaining to Equipment operation, cleaning and maintenance; Provide feedback if need.



+ Performing the GAMP assessments, FMEA assessment, 21 CFR assessments and ERES assessments.



+ 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



+ Preparation and 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



+ Prepare and review impact assessment documents







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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