MANDA SREENIVASU

The following current job responsibilities are cited below:

PRODUCT DEVELOPMENT:

• Ensure the completion of POC studies.
• Ensure and monitor the lab-scale studies.
• Follow-up and review of QTPP.
• Follow-up and review of FMEA.
• Follow-up and review of QRA.
• Review of MOC studies.
• Review of Stability Studies.

TECHNOLOGY TRANSFER:

• Review of manufacturing formula, batch size, manufacturing process instruction, and flow charts involved for execution of batches.
• Ensure that the BMR and BPR are up-to-date before execution of the batch.
• Verify all steps involved in BMR and BPR after execution of batches.
• Review of the Data integrity and compliance.
• Review of all sampling protocols involved in the manufacturing of batches.
• Stage gate clearance.

METHOD VALIDATIONS:

• Reviewed analytical method validation protocols to ensure compliance with industry quality standards.
• Enhanced sample and standard evaluation.
• Responsible for monitoring the validation of analytical methods.
• Conducted reviews of Analytical Method Validation data to ensure data integrity and accuracy.
• Conducted comprehensive evaluation of Analytical Method Validation reports.
• Reviewed and enhanced bioanalytical Method Validation protocols and reports.

METHOD TRANSFERS:

• Reviewed and enhanced protocols for analytical method transfer.
• Sample and standards review.
• Approval and execution of method transfer protocols.

REGULATORY AFFAIRS:

• Review of Product Development reports.
• Preparation of Stability Compilations.
• Preparation of Residual Solvent Reports.
• Support to the team for any queries.

VENDOR QUALIFICATIONS:

• API vendor qualifications.
• Excipients vendor qualifications.
• Review of DMFs.

EXTERNAL AUDITS:

• Scope of manufacturing facility of CMO.
• Scope of Testing Laboratories for External testing laboratories.
• Evaluate the capabilities of various departments.
• Evaluate the capabilities of the equipment.
• Verify the Quality Management Systems.
• Identify the regulatory approvals.

BIOANALYTICAL:

• Verify the Samples, Standards, and blank matrix compliance.
• Monitoring of Bio-Analytical method validations.
• Review of Bio-Analytical Method Validation data for data integrity.
• Review of Bio-Analytical Method Validation protocols and reports.

GLP ACTIVITIES:

• Quality systems creation.
• Training
• Man-related qualifications.
• Machine-related qualifications.
• Quality Management systems.
• Internal Audits.

ANALYTICAL KNOWLEDGE:

• Preparation of SOPs for regular instruments.
• 21 CFR compliance in chromatographic data.
• Verification of analytical data.
• Verification of validation data.
• Data integrity.
• Operation of analytical instruments like osmometers, KF coulometry, KF auto titrators, HPLC, etc.
• Handling of Open lab software with Agilent HPC, GC.
• Handling of EZ Chrome software with Agilent HPLCs.
• Handling of Chromeleon software with chromatographic systems.
• Audit trails verification of chromatographic data.