Quality Assurance Project Management
Resume:
Sonal Patel
Quality Assurance
Documentation
Specialist
Sonal Patel
12L Reler Lane
Somerset, NJ 08873
***************@*****.***
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Skills Analytical thinking, Communication, Leadership, Creativity, Adaptability, Decision Making, Collaboration, Teamwork, Emotional Intelligence, Project Management and Data Analysis Lead the 21st century project
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Experience Sun Pharma / Quality Assurance Documentation Specialist March 2021 - November 2023, New Brunswick
- To issue all commercial batch records for manufacturing and packaging from the copy of the Master batch record.
- To make effective all new and revised batch records given fromMSTG(Manufacturing Science and Technology
Group).
- To ensure no executive batch records pending in
manufacture department prior to making batches Effective.
- To receive and verify all Bonafide copies of master batch records for manufacturing and packaging.
- To scan all Bonafide and save as PDF to issue all manufacturing and packaging batches.
- To archive all Bonafide copies in a confidential documentation storage room and keep the PDF version in system to issue batches.
- Make obsolete all old Bonafide copies and return to MSTG.
- To do second checked by for all packaging batch records to avoid an error prior to packing any product.
- To issue all common blend and final blend batches as per planning request To issue all validation and commercial stability batches as near MSTG requirement.
- To assure the process validation program being followed and approve the process validation protocol if required.
- To initiate change controls if required.
- Document all issued numbers for change control,
deviations, planned deviations, CAPAs, OOS and OOT in an individual logbook and Excel sheet in system.
- Knowledge of material check expiration date and retest date
- Put all closing dates in logbooks and in a system when all reports are completed.
- To determine and assign the corresponding re-examination and expiration dates to the lots prior to releasing COA.
- To issue item code numbers in the system and maintain a logbook with all details of supplier and manufacturer.
- To track due dates for incidents, planned deviation, deviation, OOS, OOT and CAPAs.
- To make all new and revised SOPs effective for all departments.
- Update all revised and new SOPs and their corresponding forms after making them effective.
- Archive all New, revised and obsolete SOPs in proper binders as per the departments.
- Update all revised and new SOPs and their corresponding forms after making them effective.
- Archive all New, revised and obsolete SOPs in proper binders as per the departments.
- To track all revisions of SOPs of all departments and send a reminder to follow up.
- To issue all logbooks and notebooks of all departments like manufacturing, packaging, analytical, control substance, DEA, warehouse, Quality Assurance annually and middle of the year if the requirement is more.
- Document all issued logbooks, notebooks, batch records and archive them in proper binders.
- To issue extra pages of all manufacturing and packaging batch records as per the request during in-process.
- Make an entry of all issued extra pages for tracking purpose and archive them
- To receive all controlled documents whenever usage is over and archive them in a secure storage facility.
- Also, document in a logbook for storage to keep track of retrieval and archival of controlled documents.
- Do reconcile of all issued annual documents at the end of the year
- Archive all closed documents in proper storage.
- To assign the number to conditional release and the details maintained in a logbook
- Create conditional release labels with the expiration dates.
- To archive all Training records of employees from various department
- Knowledge of LMS(Learning Management System),
EDMS(Electronic Document Management System), SAP(System Applications products in Data Processing)
- Provide all necessary documents to FDA, visitors and auditors by putting uncontrolled copies stamp
- To maintain all inventories required for documentation. Raritan Pharmaceuticals/ IP Quality Assurance
November 2018 - August 2020, East Brunswick
- Checking and inspecting the cleaning, startup and operation of manufacturing process
- Starting from dispensing, blending, and compression to packaging lines.
- Performing In process checks for solid oral dosage forms including sampling of blend and tablets and their testing.
- Checking batch records and logbooks for completeness and correcting them.
- Guiding operators in performing their job functions in GMP compliance.
- Assist team in meeting packaging and production requirements.
- Assist with the training of personnel.
- Determine whether quality activities and related results comply with cGMP requirements.
- Perform and monitor all production floor QA related functions for the manufacturing process
- For solid dosage (tablets), liquid dosage and drug production in powder form. Perform all the
- QA related functions as per established company standards and procedures and assure that manufacturing/production is according to cGMP regulations.
- Perform activities of the floor QA such as Logbook maintenance, providing required approval for production and packaging activity and make appropriate entries in respective batch records.
- Verify raw material and components prior to usage as required and checking and monitor the
- Dispensing/weighing process, checking cleanliness, collecting in-process samples etc.
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Education Bachelor’s in arts (B.A.) with specialization in English and Computer Technology
Certificate of Nursing
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