Rahul Shah
Edison
Summary
Quality assurance professional with a proven record of driving quality initiatives and maintaining high standards. Dedication and adaptability make me a valuable asset, possessing a proactive attitude and the ability to learn quickly. Results-oriented mindset consistently exceeds targets and drives success in fast-paced environments. Proven ability to handle multiple tasks effectively and efficiently ensures no detail is overlooked.
Overview
18
18
years of professional experience
Work History
Quality Assurance Manager
CorePharma LLC
05.2020 - Current
- Quality Assurance and Compliance oversight of manufacturing and packaging facilities
- Responsible for managing the QA floor operations, QA Documentation Group, QA Investigators, Batch Reviewers, and Regulatory Compliance functions
- Scheduled and chaired quality review meetings to review effectiveness of performance mitigating risk, improving throughput and achieving customer satisfaction.
- Manage the Supplier Qualification program (Contract testing labs, Contract Manufacturers, API Suppliers, Excipient Suppliers, and Packaging Material Suppliers)
- Determined quality department standards, practices, and procedures.
- Responsible for external audits
- Perform Vendor Qualification, contact and prepare vendor qualification audit plan, questionnaire, and report
- Responsible for creating, and reviewing a Quality Agreement between CDMO, Testing laboratories
- Responsible for Quality and Compliance oversight throughout the product life cycle from development to post-commercialization for both in-house developed ANDAs and site-transferred products
- Responsible for driving continuous improvement initiatives at manufacturing sites to enhance quality and compliance with current industry standards and regulatory expectations
- Trained team members on quality assurance principles, fostering a culture of accountability and high performance.
- Facilitated communication between departments regarding quality concerns, fostering collaboration towards shared goals.
- Implemented corrective action plans based on audit findings, resulting in measurable improvements over time.
- Managed supplier relationships, enforcing strict standards for incoming materials and components to preserve product integrity and minimize rejections.
- Played a crucial role in refining company manufacturing practices by providing expert guidance on regulatory compliance matters.
- Improved customer satisfaction by ensuring all products met stringent quality standards before release.
- Led cross-functional teams to identify and resolve quality issues, fostering culture of continuous improvement.
Quality Assurance Supervisor
CorePharma LLC
12.2018 - 04.2020
- Improving Quality Assurance processes and practices
- Involved in the recruitment and mentoring of QA designees
- Developing and driving continuous improvement initiatives
- Conducting Monthly and Quarterly Quality Review Meetings with management team members
- Overseeing and coordinating the investigation of Deviation, Product Complaints, Corrective Action, and Preventive Action, and Non-Conformities
- Managing company internal and External audits programs and mock recalls ensuring GMPs compliance
- Investigating incidences of staff non-compliance with procedures
- Perform Vendor Qualification, contact and prepare vendor qualification audit plan, questionnaire, and report
- Dealing with technical issues as they arise
- Resolves issues found during manufacturing, and documentation review as directed by SOP
- Review manufacturing and packaging batch records and reports
- Prepare, review, approve, and maintain the company’s SOP and SOP system
Quality Assurance Supervisor
MSN Pharmaceutical Inc.
04.2018 - 11.2018
- Preparation, Coordination, and Implementation of SOPs, Specifications, and Various types of Formats related to SOPs
- Preparation of Equipment Qualification / Area Qualification / IPQC instrument Protocols
- Improving relationships with contractors and suppliers
- Reviewing and Approving SOPs, Qualification Protocols
- Auditing Various Packaging Component Facilities
- Support in Project and contact vendor for various requirement
- Prepare and execute Temperature and Humidity Mapping Protocol for Raw Material storage room
- Prepare and execute Qualification Protocol for Stability Chamber
Quality Assurance Compliance (QA Lead)
Heritage Pharma Labs (Emcure Pharmaceuticals USA)
06.2014 - 03.2018
- Determine whether quality activities and related results comply with cGMP requirements
- Improve Key Performance Indicators including Incoming inspection, In-process inspection, and Final product through various improvement initiatives and using Quality Management System
- Monitoring and Handling Stability Program
- Auditing Various Packaging Component Facilities
- Representing External Audit and Collecting and analyzing data for gathering audit evidence and preparing Vendor Quality System Questionnaires and Precheck list
- Preparation of Annual Product Review Report
- Reviewing manufacturing batch records, Packaging batch records
- Floor QA Activity
- Preparation, Coordination, and Implementation of Sops, Specification, and Various types of Formats related to SOP
- Designing, reviewing, and tracking CAPA & monitoring the effectiveness of CAPA
- Annual Trending report for LDN, OOS, Deviation, Change Control, Environmental, Water Purification System, and Temperature & Humidity
- Performing Product batch release tasks
- Document control and management
- Handling of internal and external calibrations of instruments and equipment
- Bi-Annual review of SOP
- Assigning change control numbers for all the CCN requests
- Assign the new SOP/QCM numbers Protocol numbers and maintain and archive those original documents
Q.A. Executive & Plant In-charge
Astral Pharmaceutical Industries (US FDA APPROVED)
12.2009 - 03.2014
- Four years of Quality oversight for aseptic processing of sterile drug products
- Handle Aseptic Process and cleanroom behavior and also be involved in the Aseptic process activity in dry powder injection
- Supervising more than45 employees in Production, Printing, Packaging, and other departments
- Coordinating and directing production levels to ensure quality specifications are met
- Overseeing, controlling, and coordinating the productivity of various departments
- Implementing quality assurance programs, maintaining appropriate records and reports, and providing training to production/packaging personnel
- Identifying and supervising correction of line faults; troubleshooting in Production, Printing, Packaging, and other departments
- Experienced in handling documentation systems, change control systems, validation, investigation of out of specification procedures and reports, incidence reports, and also of self-inspection
- Monitoring and Planning for dispatch as per schedule
- Prepare and Monitor the Validation and Re-validation schedules of process equipment, facilities, and utilities and ensure they are maintained in defined frequencies
- Responsible to handle equipment as per standard operating procedures
Quality Assurance officer
Astra Lifecare (i) Pvt. Ltd
03.2008 - 11.2009
- Worked as QA officer in the Granulation, Compression, and Packaging Department
- Experience working in a cGMP environment
- Performed various manufacturing support activities like line clearance of the room and equipment, In-process testing of tablets and capsules
- Experienced in handling documentation systems, change control systems, validation, investigation of out of specification procedures, and incidence report
- To ensure collection of the process, intermediate and finished samples of the product being manufactured
- Overseeing, controlling, and coordinating the productivity of various departments
- Maintaining appropriate records and logbooks
- Maintaining documentation like BMR, BPR, Retrieval of validation protocol, and documentation of all validation reports
- Regular basis reviewing of the B.M.R and B.P.R
Jay Formulation Ltd
01.2007 - 02.2008
- Monitoring of online production activity
- To perform and monitor In-Process Quality Assurance activity
- Physical Appearance, Color variation, Weight Variation, Hardness, Thickness, Disintegration Time, etc
- Issuance, Retrieval, Destruction, and Archival of documents
- Updating the Approved Vendor List for Raw Materials and Packaging Materials
Education
Bachelor of Science - Chemistry
M.G Science College
Master of Science - Chemistry
School of Science College
Skills
- Quality assurance management / experience
- Quality standards determination / Manufacturing processes
- Policy reinforcement
- Project management
- Goals setting / Effective multitasking
- Team building / Relationship building
- Team collaboration
Accomplishments
- Successfully implemented the Quality Management System (QMS) Modules from a Manual Paper base System
- Successfully implemented SAP Stability Module from Manual (Winproto) Stability Module
Languages
English
Hindi
Gujarati
Timeline
Quality Assurance Manager
CorePharma LLC
05.2020 - Current
Quality Assurance Supervisor
CorePharma LLC
12.2018 - 04.2020
Quality Assurance Supervisor
MSN Pharmaceutical Inc.
04.2018 - 11.2018
Quality Assurance Compliance (QA Lead)
Heritage Pharma Labs (Emcure Pharmaceuticals USA)
06.2014 - 03.2018
Q.A. Executive & Plant In-charge
Astral Pharmaceutical Industries (US FDA APPROVED)
12.2009 - 03.2014
Quality Assurance officer
Astra Lifecare (i) Pvt. Ltd
03.2008 - 11.2009
Jay Formulation Ltd
01.2007 - 02.2008
Bachelor of Science - Chemistry
M.G Science College
Master of Science - Chemistry
School of Science College
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