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Senior Executive (Validation Specialist)


Visakhapatnam, AP 530003
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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


**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


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.
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