Sonal Patel

Quality Assurance

Documentation

Specialist

Sonal Patel

12L Reler Lane

Somerset, NJ 08873

732-***-****

ad4d5r@r.postjobfree.com

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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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