Unicon Pharma Released Job Openings On 19/01/2023.Unicon Pharma is a leading life sciences recruitment firm that provides services to top pharmaceutical, biopharmaceutical, biotechnology, and medical device companies nationwide. Our mission is to deliver the best experience for our clients and candidates on every engagement, big or small.
Unicon Pharma Recruiting B.Pharma,B.Sc,B.Tech Graduates required relevant experience for Validation Engineer (CQV, Equipment & Cleaning) Position.Complete Details for the Validation Engineer (CQV, Equipment & Cleaning) as follows.
Important Details :
- Location : United States (USA), Various Locations
- No of Vacancies:05
- Details of Salary:Not Disclosed
- Opening date for online Application: 19/01/2023
- Mode of application :Online
- How To Apply: At the End of the Article We Have Provided Source Link,Please Go through that and Follow Necessary Steps
Job Description/Skills Required
- Perform validation activities for the processes, facilities, utilities, manufacturing, and laboratory equipment in the pharmaceutical industry in compliance with FDA regulations, Quality Management systems, Good Manufacturing Practices and 21 CFR Part 11 (Electronic Records and Signatures).
- Develop and execute the validation master plan, validation project plan, risk assessment, user requirements, design qualification and life cycle documents for any improvements in the production methods and ensure compliance with cGMP regulations.
- Generate the User Requirement Specifications and Impact Assessments to ensure the functioning of the equipment and determine the impact of the system on the product quality.
- Perform design review to ensure the equipment is installed and operates according to the User Requirement Specifications.
- Perform Commissioning, Qualification and Validation of the equipment and systems.
- Generate and execute validation protocols (IQ, OQ and PQ) for pharmaceutical drug manufacturing and laboratory equipment, including but not limited to HEPA filters, controlled temperature units, manufacturing equipment and packaging line equipment.
- Characterize equipment operation processes and define critical process parameters and critical quality attributes
- Write and execute the official test scripts, complete associated documentation for equipment and processes to ensure the test results are reported accurately.
- Perform site activities by attending the Factory Acceptance and Site Acceptance tests, execute the Commissioning, Qualification and Validation protocols, compile the data, and prepare summary reports for the completed Commissioning, Qualification and Validation protocols.
- Initiate and manage validation deviations and investigations in the development process of execution activities and equipment functioning. Analyze the investigations to identify the root cause of the deviations to define a corrective action to reduce the impact on product quality.
- Co-ordinate and interface with operations, quality assurance and project delivery department, to develop supporting documentation, validation deliverables to ensure compliance with cGMP regulations and to witness and troubleshoot the equipment as required.
- Develop, understand, and utilize the Standard Operating Procedures for the proper functioning and process of the equipment operation.