Yamuna Pedimina

Work Experience (2.8 years in Quality Assurance as a Technical Trainee).

Documentation: As a Technical Trainee who joined in Documentation.

May 2023 to August 2024

• Maintaining and following the cGMP guidelines, standard operating procedures, and company policies.
• Preparation of standard operating procedures and respective formats related to Quality Assurance.
• In documentation, I have done all the GMP documents, including issuance, retrieval, and distribution records.
• Maintaining archival records with easy traceability and an archival Excel sheet maintained.

Annual Product Quality Review (APQR): Aug 2023 to Dec 2024.

• Preparation and review of the Annual Product Quality Review (APQR), including manufacturing data, analytical data, validation data, QMS data, qualification details, vendor details, and external laboratory details.

Batch Release Activities: Aug 2023 to Present

• Looking at executed batch manufacturing records and batch packaging records.
• To prepare and review the batch release documents as per the dispatch plan.
• Mail communication and responses are given to customers, internal units, and the marketing team.
• Responsible for providing responses to customer and regulatory queries related to batch release activities.

Validations: Jan 2024 to present

• Online monitoring of validation activities (I occasionally support in Process Validation Reports and Hold Time Reports).
• I will do this during Batch Release time as part of the validations, continuous process verification, and continuous packaging reports.

Regulatory filing: May 2024 to present

• I am doing a submission in the regulatory filing, so if there are any customer-related queries, I will check them out.

Change Controls: Dec 2025 to present

• Looking at change control initialization, closures, and deviation logins.