Wasim Shaik
Expert- Quality Services
Hyderabad
Summary
Quality Management Professional with over 11 years of experience in pharmaceutical quality systems, including QMS, process and cleaning validations, CSV, global audits, and end-to-end plant setups. Proven track record of leading cross-functional initiatives across international sites, driving compliance, operational efficiency, and process harmonization
Overview
11
11
years of professional experience
7
7
years of post-secondary education
Work History
Expert- Quality Services
Sanofi
10.2024 - Current
- Prepared and analyzed monthly and quarterly trending reports across Sanofi.
- Streamlined novel trending governance procedure, achieving harmonization across multiple sites, countries, and External Manufacturing Sites (EMs).
- Designed and implemented a one-click supplier identification process, streamlining procurement workflows and reducing manual cycle time by over 50%.
- Led an enhanced knowledge transfer by identifying process scope, aligning with stakeholders, and streamlining procedures to ensure seamless operational readiness and harmonization.
- Developed Power BI dashboards to monitor the monthly health status of EMs, enabling data-driven decision-making.
Associate Manager- Quality Operations
Sandoz/ Novartis Private limited
03.2021 - 10.2024
- Managed end-to-end complaint intake and assignment processes, ensuring timely supplier engagement and regulatory compliance.
- Performed quarterly complaint and deviation trending and reporting, providing actionable insights.
- Acted as single point of contact for self-inspection and global audits.
- Reviewed complaint records in GxQM and coordinated with stakeholders for SLA finalizations and KPI metrics.
- Imparted training as a Certified Trainer, enhancing team capability and onboarding efficiency.
- Escalated GxP and non-GxP issues, managed issue logs, and ensured compliance with internal SOPs.
- Provided QA approvals for Biosimilar segment complaints and supported internal and external audits.
Sr. Executive-Quality Assurance
AET LABORATORIES Pvt, Ltd
05.2019 - 03.2021
- Oversaw computer system validations and third-party audits.
- Responsible for the third party audits for the service providers and secondary packing materials.
- Led site-wide cleaning validation and mock recall processes.
- Responsible for preparation and review of process validation protocols and reports, equipment qualifications review.
- Reviewed process validation, equipment qualifications, and risk assessments.
- Facilitated regulatory and customer audits at the site.
- Providing audit compliance to the regulatory and customer audits and facilitation of the audits at site (Regulatory and customer audits).
Executive- Validations and Quality Operations
Mylan Laboratories Limited
02.2016 - 05.2019
- Preparation of Process validation, Cleaning validation, transit trails studies, cross contamination studies.
- Handling of Engineering related SAP transactions.
- Review of qualification documents.
- Review of Process performance qualifications protocol and Process performance qualification reports of the exhibit and commercial batches.
- Accountable for Cleaning Validation activities at site.
- Responsible for preparation of continuous process verification protocols and reports.
- Responsible for Annual review of cleaning validation status and periodic monitoring of Cleaning efficiency.
- Preparation of transit trial protocols and reports.
- Review of Product transfer document, risk assessments, technology transfer protocols, license particulars, pack mode configurations.
- Review of Process evaluation protocols and Process evaluation reports for scale up batches.
- Review of packing validation protocol and packing validation reports.
- Review of IQ, OQ,PQ documents of equipment related to Quality control, Warehouse & Production.
Validation Officer
M/s Medreich Limited
05.2015 - 02.2016
- Handling of Installation, Operational and Performance qualifications of production equipment.
- Preparation of BMR, BPR, Process validation protocol and reports Preparation of all documents associated with cleaning validations.
- Handling of cleaning validation, Process validation and hold time studies.
- Execution of Automatic storage and retrieval system performance qualification.
- Hold time studies for clean and dirty equipment.
Trainee- Quality Assurance
Natco Private Limited
03.2014 - 05.2015
- Performing in-process checking of packaging activity and manufacturing activity for ensuring compliance with the guidelines and standard operating procedures.
- Making annual product reviews and monthly trends.
- Reviewing the batch manufacturing records and batch packaging record.
- Reviewing the retention samples and destruction of expired samples.
- Responsible for release of batch in between the processing steps through SAP.
- Line clearance for warehouse dispensing, production, primary and secondary & Finished good pelleting.
- Sampling of in process, blend, bulk and finished product.
Education
Master of Pharmaceutics - pharmaceutics
SRR College of Pharmaceutical Sciences
03.2011 - 01.2014
Bachelor of Pharmacy - undefined
Rajiv Gandhi University of Health sciences
03.2006 - 03.2010
Skills
Process and cleaning validation
Minitab
Data Visualizations
Equipment qualifications
HVAC Validations
Calibrations
Critical thinking
Websites
Awards
- Harmonization of the investigation reports, Executed the project as a head for the project, coordinated with 50 suppliers for the harmonization and achieved 63 % turnout rate and reduced the throughput rate from 45 minutes to 20 minutes., 4
- Operational Excellence Mylan Laboratories, 01/02/16, Implemented operational excellence project in the warehouse and documentation cell under mentoring of Head Quality operations. Implemented Kaizen 5 S in both the areas within 6 months of the project inception.
Academic Accolades
- Bagged All India rank 3187 rank GPAT in 2010.
- Secured 152 rank in PGECET-2010, Andhra Pradesh.
Accomplishments
- Designed and implemented a one-click supplier identification process, streamlining procurement workflows and reducing manual cycle time by over 50%.
- Developed Power BI dashboards to monitor the monthly health status of EMs, enabling data-driven decision-making.
- Executed the project as a head for the project “Harmonization of the investigation reports”, Coordinated with 50 suppliers for the harmonization and achieved 63 % turnout rate and reduced the throughput rate from 45 minutes to 20 minutes (Team Size 4).
- CPV implementation at site: Streamlining of legacy products, Evaluation of the data generated during validations and deciding CMA, CPP and CQA for the legacy products, Evaluation of the deviations, incidents for the legacy products and aligning for the CPV phase.
Timeline
Expert- Quality Services
Sanofi
10.2024 - Current
Associate Manager- Quality Operations
Sandoz/ Novartis Private limited
03.2021 - 10.2024
Sr. Executive-Quality Assurance
AET LABORATORIES Pvt, Ltd
05.2019 - 03.2021
Executive- Validations and Quality Operations
Mylan Laboratories Limited
02.2016 - 05.2019
Validation Officer
M/s Medreich Limited
05.2015 - 02.2016
Trainee- Quality Assurance
Natco Private Limited
03.2014 - 05.2015
Master of Pharmaceutics - pharmaceutics
SRR College of Pharmaceutical Sciences
03.2011 - 01.2014
Bachelor of Pharmacy - undefined
Rajiv Gandhi University of Health sciences
03.2006 - 03.2010
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