JOB DESCRIPTION - Establish Qualification approach for complex equipment and process. Ensure establishment of Global Qualification standard for equipment/system in formulation site (Drug Product).
- Establish Global SOP for various system to optimize the validation practices usage and cost implicated on qualification.
- Establish Qualification strategy for Greenfield and Brownfield projects.
- Resolve issue escalated from sites pertaining to equipment qualification GMP process and sterility assurance.
- Establish Qualification strategy for Process control system.
- GMP Audit support with respect to Audit readiness Response.
- Develop capability of Equipment qualification team.
- Mentor Qualification leads and SMEs across regions.
- To centrally organize guide control the qualification and validation programmed of each site.
- Plan for improvement in line with best industrial cGMP and regulatory requirement.
- Support the site team in evaluating the skid design.
- Identify the training needs of Qualification personnel across the sites. Training of Qualification team on latest trends in Qualification of Clean utilities Facility Equipment
- Review of Qualification related to GSOP/s & GQS.
- To identify the lapses and possible improvement in the system in line with regulatory and industrial practices.
- Coordinating the sites for effective completion of qualification activity within stipulated timelines.
- Guidance & Trouble shooting during Qualification activity.
- To identify the new software for Qualification activity.
- Standardization of Equipment URS. Harmonization of Qualification Protocol Report template & Formats.
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Required Skills:
VMP Validation Equipment Qualification IQ OQ PQ FAT SAT Cleaning Validation
JOB DESCRIPTIONEstablish Qualification approach for complex equipment and process. Ensure establishment of Global Qualification standard for equipment/system in formulation site (Drug Product).Establish Global SOP for various system to optimize the validation practices usage and cost implicated on ...
JOB DESCRIPTION - Establish Qualification approach for complex equipment and process. Ensure establishment of Global Qualification standard for equipment/system in formulation site (Drug Product).
- Establish Global SOP for various system to optimize the validation practices usage and cost implicated on qualification.
- Establish Qualification strategy for Greenfield and Brownfield projects.
- Resolve issue escalated from sites pertaining to equipment qualification GMP process and sterility assurance.
- Establish Qualification strategy for Process control system.
- GMP Audit support with respect to Audit readiness Response.
- Develop capability of Equipment qualification team.
- Mentor Qualification leads and SMEs across regions.
- To centrally organize guide control the qualification and validation programmed of each site.
- Plan for improvement in line with best industrial cGMP and regulatory requirement.
- Support the site team in evaluating the skid design.
- Identify the training needs of Qualification personnel across the sites. Training of Qualification team on latest trends in Qualification of Clean utilities Facility Equipment
- Review of Qualification related to GSOP/s & GQS.
- To identify the lapses and possible improvement in the system in line with regulatory and industrial practices.
- Coordinating the sites for effective completion of qualification activity within stipulated timelines.
- Guidance & Trouble shooting during Qualification activity.
- To identify the new software for Qualification activity.
- Standardization of Equipment URS. Harmonization of Qualification Protocol Report template & Formats.
|
Required Skills:
VMP Validation Equipment Qualification IQ OQ PQ FAT SAT Cleaning Validation
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Posted on:
7 hours ago
Vacancies:
1 Vacancy
