Sign In
 [New User? Sign Up]
Mobile Version

Executive (Validation Engineer)


Visakhapatnam, AP 530003
Apply on the Company Site
  • Save Ad
  • Email Friend
  • Print
  • Research Salary

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


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


+ 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
Powered ByLogo

Featured Jobs[ View All ]

Featured Employers [ View All ]