SAP
Roshan Patil
Assistant Manager - Packing Operations
Nashik
Summary
Results-driven Quality Assurance professional with over 11 years of experience in Packaging Operations and GMP documentation, currently serving as Assistant Manager at GlaxoSmithKline Pharmaceuticals Ltd. in Nashik. Expertise includes cGMP, Quality Management Systems (QMS), Auditing, and Risk Management, ensuring compliance and operational excellence. Recognized for strong communication skills, collaborative teamwork, and a rapid learning curve, along with analytical and logical problem-solving capabilities. Committed to driving quality improvements and fostering a culture of continuous enhancement within the organization.
Overview
12
12
years of professional experience
1
1
Certification
3
3
Languages
Work History
Assistant Manager - Packaging Operations
GlaxoSmithKline Pharmaceuticals Limited
06.2022 - Current
- Led Packing Line 1 operations, managing shift activities to ensure safety, quality, compliance and on-time delivery for creams and ointment batches.
- Conducted process confirmations against the 4Ms (Material, Manpower, Method, Measurement) to maintain cGMP, regulatory and QMS standards.
- Ensured adoption of Leader Standard Work and Standard Work for frontline roles; coached staff to improve performance and adherence.
- Performed L1 audits per schedule and responded to internal/external audits, ensuring timely closure of findings.
- Drove continuous improvement initiatives, deploying GPS problem-solving to eliminate recurring safety, quality and productivity issues.
- Identified and resolved real-time production issues with staff to minimize disruptions and rework.
- Managed deviation procedures and problem-solving workflows to prevent recurrence and maintain product integrity.
- Led site-wide projects and participated in tier I & II Performance Management System (PMS) meetings to support operational targets.
- Prepared SOPs and work instructions, reviewed APQR documents, and raised/executed change controls within QMS timelines.
- Acted as Department Data Integrity (DI) and CSV champion, advising on risks, initiatives and compliance best practices.
- Provided coaching and development to operators, holding team members accountable and improving overall capability and shift performance.
- Provided input to GSK systems (dMERP, VQD, VQMS, Workday) to ensure accurate records and continuous performance tracking.
Executive QA (QMS + IPQA + Batch Disposition)
GlaxoSmithKline Pharmaceuticals Limited
02.2016 - 05.2022
- Conducted knowledge-sharing sessions across teams to enhance capability and transfer critical QA and operational knowledge.
- Performed pre-assessments of change controls within the area of operation to ensure completeness and regulatory alignment prior to implementation.
- Executed impact assessments of deviations on product quality, patient safety, stability, validation status and regulatory obligations; initiated appropriate containment and corrective actions.
- Drove Quality Improvement Projects (QIP) to strengthen selected quality systems, reduce risk and improve compliance metrics.
- Led routine Gemba walks to identify process gaps and ensured timely closure of Gemba observations.
- Ensured shop-floor activities complied with regulatory requirements and QMS procedures; maintained inspection readiness at all times.
- Managed timely response and closure of audit observations for the area, supporting internal and external inspections.
- Performed in-process checks and online document reviews to verify adherence to SOPs, batch records and control plans.
- Ensured release of bulk and finished products met statutory and QMS requirements, reviewing master BMRs and draft MFRs for products manufactured/packed in the area.
- Raised deviations and incidents with rapid response in TrackWise; participated in root cause analyses and implemented corrective/preventive actions.
- Reviewed and maintained SOPs for the area to ensure they were in place, in use and compliant with regulatory and QMS expectations.
- Conducted on-the-floor training and coaching to build operator capability and ensure consistent application of Standard Work.
- Identified, assessed and proactively mitigated departmental risks in line with risk management principles.
- Supported site validation activities and provided QA input to ensure validation deliverables met quality and regulatory standards.
- Supported GPS rollout and QIP implementation within the Quality function to drive continuous improvement.
- Led 5S, poka-yoke and Kaizen initiatives to enhance process reliability, reduce defects and improve operational efficiency.
Executive QA (QMS + IPQA + Batch Disposition)
GlaxoSmithKline Pharmaceuticals Limited
02.2016 - 05.2022
- To conduct knowledge sharing sessions within and across team to enhance the capability and knowledge of different topics.
- To perform pre-assessment of change controls raised in area of operation.
- To perform Impact assessment of Deviations on Product Quality/Patient Safety, Stability, Validation Status and Regulatory.
- To drive QIP for improvement of selected Quality systems.
- Perform routine GEMBA and ensures timely closure of GEMBA observations.
- Ensure that the activities on shop floor are followed as per compliance with regulatory and QMS requirements.
- Ensure timely compliance to all audit observations in the area and inspection readiness at all time.
- Perform In-process checks & online document review.
- To ensure release of bulk and finished products, meeting the statutory and QMS requirements, to market.
- Reviews Master BMR / draft MFR of products manufactured and packed in area of operation as per regulatory requirements and SOPs.
- Raise Deviations/ Incidences in Dept. with Rapid Response in TrackWise & participation in RCA's.
- Review of SOPs and ensure SOPs for area are In Place, In Use and meet all regulatory and QMS requirements.
- Conduct trainings and coaching on shop floor for capability building.
- Ensure that all risks for department are identified, assessed and mitigated proactively in accordance with risk management principles.
- Provide support for various validation activities on site.
- Supports GPS roll out at site & Supports implementation of QIP for Quality department.
- Carrying out 5S, poka-Yoke and Kaizen activities for continuous improvements.
Associate Manufacturing documentation
GlaxoSmithKline Pharmaceuticals Limited
02.2014 - 12.2015
- Gap analysis of standard operating procedures in view of the Current Guidelines and Corporate Quality Procedures.
- Review and analysis of the manufacturing process of different products to stabilize the product and process robustness.
- To prepare SOP, BMR, BPR and related GMP documents for the site.
- Online review of batch records & related documentation.
- Tracking and closure of Change Control actions and CAPA in Trackwise.
- To review or audit the implemented system for further improvement requirements.
Education
Master of Pharmacy - Pharmaceutics
S.M.B.T Collage of Pharmacy
Nashik, Pune09.2013
Bachelor of Pharmacy - undefined
S.M.B.T Collage of Pharmacy College
Nashik, Pune10.2011
Diploma in Pharmacy - undefined
N.D.MV.P Pharmacy College
Nashik04.2008
Skills
Leadership: Shift management, team supervision, performance coaching, accountability
Accomplishments
- GOT Silver Award for pivotal role in the 'QR Code Printing, Inspection and Verification on cloud' Project, ensuring GSK's compliance with India's Ministry of Health and Family Welfare's stringent anti-duplication regulations.
- Got Global Employee Recognition Bronze Award at GSK from Customer Supply Chain Lead for contribution to make Pack change project for Betnovate N 20 g to 25 g pack, a success in less than 4 months.
- Got Global Employee Recognition Silver Award at GSK from site director for truly exemplifying our Values & Expectations, particularly Accountability, Teamwork and Patient Focus in the context of the COVID-19 pandemic.
- Got Global Employee Recognition Award at GSK for excellent engagement & ownership in handling of different issues and investigation to find out the correct root cause which shall help to avoid recurrence.
- Got Global Employee Recognition Award at GSK for excellent contribution during the Audit & Assurance preparation by doing the data trending and analysis to support readiness of Eltroxin products performance pack.
- Got Global Employee Recognition Award at GSK for work towards the site performance by keeping focus on quality compliance and sense of urgency in mind.
- Got Global Employee Recognition Award at GSK for GEMBA kaizen to store printed packing materials.
Software
Trackwise
Veeva Quality
CDMS
Certification
Oranage Belt
Timeline
Oranage Belt
04-2025
Assistant Manager - Packaging Operations
GlaxoSmithKline Pharmaceuticals Limited
06.2022 - Current
Executive QA (QMS + IPQA + Batch Disposition)
GlaxoSmithKline Pharmaceuticals Limited
02.2016 - 05.2022
Executive QA (QMS + IPQA + Batch Disposition)
GlaxoSmithKline Pharmaceuticals Limited
02.2016 - 05.2022
Associate Manufacturing documentation
GlaxoSmithKline Pharmaceuticals Limited
02.2014 - 12.2015
Bachelor of Pharmacy - undefined
S.M.B.T Collage of Pharmacy College
Diploma in Pharmacy - undefined
N.D.MV.P Pharmacy College
Master of Pharmacy - Pharmaceutics
S.M.B.T Collage of Pharmacy
Personal Information
- Date of Birth: 1989-05-20
- Marital Status: Married
Recognitions
- OB certification by GSK for DIMAC problem solving.
- Sliver Award by GSK for QR code implementation on time as regulatory requirements in Aug 2023.
- Sliver Award for new strength of T- Bact Ointment in short times considering market requirements.
- Bronze Award for best investigation for strip packing area deviation.
- Got Global Employee Recognition Award at GSK from Customer Supply Chain Lead for contribution to make Pack change project for Betnovate N 20 g to 25 g pack, a success in less than 4 months.
- Got Global Employee Recognition Award at GSK Excellent contribution during the Audit & Assurance preparation by doing the data trending and analysis to support readiness of Eltroxin products performance pack.