Quality Assurance ( Process Validation, Qualification )

Department : Quality Assurance (Process Validation, Qualification )

Designation : Officer / Executive

Experience : 2 to 6 Years

Location : Bavla, Ahmedabad

Education : M. Pharma / B. Pharma / M. Sc

Job Description : ( Process Validation )

• To prepare standard operating procedure.
• Issuance of controlled Format to concern department.
• Provide the required documents to regulatory for dossier submission.
• Follow – up with concern department to complete the documentation.
• To prepare protocol for Process Validation, cleaning validation and hold time validation study.
• To execute process validation, hold time validation and cleaning validation activity and co-ordination with all departments for planning.
• Review of protocols for process validation, cleaning validation and hold time validation
• Preparation and communication of critical process parameters based on process validation study
• Preparation and communication of hold time to production based on obtained hold time study reports.
• Sample collection, submission, report compilation and preparation of summary report for process validation, cleaning validation and hold time validation.
• Issuance of Hold time Validation, cleaning validation and Process Validation Protocol.
• Any other work assigned by HOD.

Job Description : ( Qualification )

Must Exposure in Parenteral Background

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Skills Required

Cleaning Validation, Vendor Audit, Process Validation