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Worked in previous job as Senior Auditor – Asia Pacific in Astra Zeneca Pharma India Limited, responsible for audits of Astra Zeneca manufacturing sites and R&Ds, supplier audits (API, Excepients, Packaging Materials), and Third Party Contract Manufacturing Audits for Asia Pacific Region. Overall having 14 years of experience for regulated markets in Quality ranging from Manufacturing Quality, Audits, Trainings, QMS (Deviations, Investigations, OOS, Change Controls, CAPA management), Vendor Approvals, Supplier Management, Project Management, Regulatory Submissions and Compliance.


Current Experience

  • QA / QC Associate Toronto, ON, Canada
    Since October 2015

    Job Responsibilities

    • Responsible for all quality operations for 2 sites
    • Oversee the operations of the Quality Unit
    • Responsible for review and approval of Deviations, Change Control, CAPAs, Investigations
    • Approve SOPs and supplier qualification
    • Trainings, internal and external audits
    • Batch release and retain sample management
    • Manage inspections by regulatory agencies and customers
    • Project management for new upcoming site in US
    • Manage team of 6 people for Quality and Operations


    • Heavily contributed in establishing two new sites – Canada (Toronto) and US (Orlando)
    • Faced US FDA Audit and Health Canada audit with successful approvals

Past Experience

  • Senior GMP Auditor - Asia Pacific
    November 2014 --- July 2015
    Job Responsibilities • Conduct complex and demanding domestic, regional and international audits for suppliers of API, excepients, finished dosage form manufacturers, packaging components, chemicals & contractual services. • Plan, coordinate & conduct scheduled / unscheduled audits of internal cross-functional AZ departments including manufacturing sites and R&Ds to ensure compliance to cGMPs and AZ standards. • Develop and interpret audit findings across scope of worldwide audit group to communicate trends and provide recommendations to address such developing trends in proactive manner. • Preparation and review of auditor training modules and SOPs • Cross functional interactions with manufacturing sites and related departments like sourcing, supply chain QA and R&D • Manage all audits through Track Wise and SharePoint • Providing trainings to the internal functional departments and manufacturing sites Achievements • Experienced lead Auditor and Support Auditor for national and international audits • Completed 15 audits in 10 month

  • Senior Manager-Global Quality
    December 2009 --- November 2014
    Job Responsibilities • Responsible for review and release of each batch manufactured at third party site prior to dispatch to a Mylan affiliate in U.S., Canada and European countries. • Part of the technical team with third party for the new product transfers and their regulatory submissions till commercialization and thereafter. • Review of investigations and deviations at the TP as applicable for customer complaints, returns, and recalls of Mylan product to ensure root cause is identified and accurate. • Handling of Deviations/ Change Controls in Trackwise • Coordinate across departments like supply chain, business development and operations for project management and new product launches. • Perform Audits for • contract manufacturing sites identification, vendor audits, internal quality audits (National and International Sites). Achievements • Initiated the concept of weekly trainings at third party for strengthening their systems • Initiated the concept of Knowledge Sharing Mails and duly recognized by top management • Represented the third-party quality for the Mylan’s Global Quality Meet, at Annapolis U.S. in April, 2012. This also included the technical trainings on “Auditing Techniques” & Corporate Quality audits. • Faced U.S. FDA auditor and MHRA auditors at Third Party in 2012.

  • Asst. Manager-Quality Assurance
    August 2006 --- December 2009
    Job Responsibilities • Manage a team of quality persons to achieve routine & regulatory compliances and continuous improvements as per cGMP norms through handling of Change Controls, Incident, Deviations and OOS. • Review and approval of GMP documents like batch records and validation protocols • Trainings – organised & imparted weekly training programs at various national and international locations • Review and compiled documents for CMC sections for regulatory submissions of documents for U.S. Markets (ANDA), Health Canada (ANDS), E.U. (MAA) and ROW markets for tablets and injectables. • Acted as internal auditor and part of team for vendor approvals, internal audits (For FKOL National and International Manufacturing Sites) • Planning of activities to achieve timely preparation and submissions of documents for batches of exhibit, technology transfer and new product transfers • Acted as Global Quality representative for Internal Magazine ‘Connect’ for two Baddi plants • Managing ‘War Room’ for all the audits. Achievements • Initiated the weekly training programs ‘Friday Meets’ and running it successfully for more than three years • Selected to represent Indian manufacturing operations for the Quality Management Workshop held in Oberusel, Germany (8th September – 10th September 2009) • Conducted Internal Quality Audits for 2 International Manufacturing Locations (U.K. and Germany) • Audits Successfully Faced: 2 MHRA, 3 U.S. FDA (India and UK manufacturing location), 1 ANVISA, GCC and Korean FDA, handled the backroom as ‘documents in charge’ for all above audits • Got double promotion to Asst. Manager within 1.8 years due to exceptionally satisfactory performance • Submission of documents for dossiers of 6 ANDA, 1 PAS, 6 MAA, 2 ANDS and 60 lesser regulated markets for tablets and injectables • Got appreciation from U.S. FDA auditors for documents retrievability at U.K. manufacturing location • Part of the team for establishing, commissioning of new formulation manufacturing unit for Sterile and Oral Solids

  • Executive - Quality Assurance
    April 2004 --- August 2006
    Job Responsibilities • Member of Process Validation Team and responsible for preparation and execution of validation protocols. • Preparation & reviewing of SOPs, Technical Directions, Stability Protocols, Specifications, STPs. • Core team member in the implementation of SAP (Version 4.7, Patch Level 22) for Quality Module at Panacea Biotec Ltd., at Delhi, Baddi and Lalru; India. Managed and Reviewed Master Data • IPQA operations Achievements • Part of the team for establishing, commissioning of new formulation manufacturing unit for Sterile and Oral Solids as Quality Assurance personel managing documentation team and IPQA team. Job Responsibilities •Member of Process Validation Team and responsible for preparation and execution of validation protocols. •Preparation & reviewing of documents like SOPs, Technical Directions, Stability Protocols, Specifications, STPs •Core team member in the implementation of SAP (Version 4.7, Patch Level 22) for Quality Module at Panacea Biotec Ltd., Delhi, Baddi and Lalru, India. • Managing team for IPQA operations

  • Quality Assurance officer
    January 2004 --- April 2004
    •Working for the In process Quality Assurance activities in various departments of a formulation unit and knowledge of ERP systems.

  • Medical Sales Representative
    December 2000 --- September 2001
    Worked as Professional Sales Representative, promoting various products through sales for asthma, childcare and cardiac care.


LinkedIn Assessment :
ANDASOPGMPValidationRegulatory affairsPharmaceutical IndustryQuality SystemCleaning ValidationRegulatory submissionsCAPALaboratoryGLPFDALeadershipRegulatory RequirementsQuality ManagementTechnology transferOperational ExcellencePharmaceuticsAuditingEmployee TrainingSOPStandard Operating Procedure (SOP)

Skills and Expertise

Self Assessment :
auditManage Quality Management System (QMS) documentationDossier Create SOPs Design case record formsTrainingSupplier Management


  • Post Graduate Diploma in Pharmaceutical Regulatory Affairs from Jamia Hamdard in 2010
  • M.Pharm in Natural Products from Panjab University in 2003
  • Bachelors in Pharmaceutical Sciences in Pharmaceutical Sciences from Dr. K. N. Modi Institute of Pharmaceutical Education and Research in 2000


BrightOwl Assessment:
Self Assessment:
Full Proficiency

Work Preferences

  • Notice Period:
    2 weeks
  • Work From Home:
    Yes, 0 to 5 days per week
  • Work Regime:
    Permanent position
  • International:

Area / Region

Toronto, ON, Canada


Driving License
  • Yes