We are looking for Candidates having Minimum Experience of 4 Years in QA from Fine / Specialty Chemical / Intermediates Manufacturing Industry.
- Candidates should have good communication skill and team working spirit.
Responsible for plant QA activities.
- Responsible for release of raw, packing materials and finished products.
- Responsible for compliance of Quality management system (QMS).
- Responsible for review and approval of QMS, GMP and GLP documentations.
- Responsible for review and approval of standard operating procedures (SOPs) of all the functions in the organization.
- Responsible for online monitoring of production activities.
- Responsible for Handling of change control, Deviations their impact assessment and closer and its tracking and follow up with concern for effective implementation.
- Responsible for internal Audits and Customer Audits of the plant and their compliance.
- Responsible for fill up Customer VQ documents and forward to them for their evaluation.
- Review of Batch Manufacturing and Batch packing records and prepare Batch Release note.
- Responsible for line clearance & In process checks, monitoring during manufacturing and packaging.
- Execution of Hold time study for intermediate products and Establish Hold time period for the same.
- Responsible for conducting in-house ISO-QMS, GMP and GLP trainings.
- Responsible for handling customer complaints.
- Responsible for Vendor Qualification and Vendor Audits.
- Responsible for Preparation and Review of Annual Product quality report.
- Responsible for Preparation of Process Validation Protocol and Report.
- Preparation of DMF filing would be preferred.
