Priyashree S. Khotre

Sr. QA Manager

Quantime World Pvt. Ltd

12.2018 - Current

Company Overview: I am currently working at Quantime World Pvt Ltd as a Senior QA Manager.
My organization deals in end-to-end solutions in clinical research.
The services we provide, in brief, are as follows: clinical trial supplies storage and distribution, secondary labeling and packaging, logistics, IWRS, ancillary and comparator procurement, returns and destruction, document archival, regulatory support, and global clinical trial supply management.
To ensure the maintenance of cGMP in the facility.
To work as an internal quality auditor for the department, system, and project-specific internal audits.
Complaint, CAPA, deviation, change control, incidence, QRM investigation, and its documentation.
ISO-related documentation and accreditation-related activities completion, participation in ISO audits.
To prepare, review, and maintain the apex documents, such as VMP, BCP, SMF, QM, etc.
To review temperature mapping activities, reports, equipment qualification, and validation activities in the facility.
External audit by customers and regulatory authorities, coordination, audit response, and its documentation.
Management of document archival and retrieval records.
Vendor, Depot, and CP vendor management: audit, reporting, and follow-up for response and coordination with vendors.
SOP preparation, training, and related documentation, along with document issuance.
Regulatory submissions of CDSCO and local FDA for secondary packaging and labeling activities as and when required.
All types of documentation reviews and their approvals, which are prepared by other departments and QA, are conducted as needed.
Incoming material inspection, line clearance for received material.
Quality checks of shipment activities.
Operation-related activities, line clearance, and in-process quality checks.
Final BPR release, batch packaging record review, and documentation.
Performing a whole product recall and mock recall procedure as per SOP, along with its documentation.
Developed and implemented quality assurance policies and procedures.
Trained new members on existing processes and tools used in the team.
Managed the daily activities of a QA team ensuring that deadlines were met.
Maintained up-to-date knowledge of industry trends and changes in technology related to Quality Assurance practices.
Provided feedback on usability and suggest enhancements to improve product quality.
Documented all phases of QA process including test plans, scripts, execution results, bug report for computer system validations.
Collaborated with developers to resolve technical issues in a timely manner.
Identified root cause of bugs and defects and provided solutions for them.
Conducted system integration tests to ensure proper functioning of the application as a whole.
Analyzed test results and reported any issues identified during testing.
Performed manual testing of software applications to identify defects.
Created test plans, scenarios, scripts, or procedures.

Summary

Overview

Work History

Sr. QA Manager

Site Solutions executive

CRC

Education

Diploma in GMP -

PG Diploma in Clinical Research Operations - Clinical Data Management and Pharmacovigilance

B. Sc -

CBSE 12th -

CBSE 10th -

Skills

Internshipsummary

Conferencesseminarstraining

Organizationdescription

Personal Information

Languages

Timeline

Sr. QA Manager

Site Solutions executive

CRC

Diploma in GMP -

PG Diploma in Clinical Research Operations - Clinical Data Management and Pharmacovigilance

B. Sc -

CBSE 12th -

CBSE 10th -

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