Contact Information

T: 905.363.1182 x.256
F: 905.542.7981

TF: 1.877.877.5152 x.256

2550 Argentia Road •  Suite 119 •  Mississauga ON • L5N 5R1
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Lead Consultant

Samiha Haque has a wide range of expertise in pharmaceutical compliance with some of the major pharmaceuticals in Canada. Her background includes experience in managing the companies Drug Establishment Licence, Regulatory Services, Alternate Site Retention, managing Quality Systems, assessing gaps, making revisions to Quality Agreements, preparing for external audits, enforcing corrective actions, conducting self-inspection audits, risk assessment and deviation investigation among other GMP compliance areas.

Skills and Highlights, Big projects

Quality Control (QCO)

  • Write, revise and maintain internal Standard Operating Procedures and Work Instructions

  • Subject matter expert in developing, implementing, and maintaining the Drug Establishment Licence Tracking Application Database

  • Drafted, Assessed gaps and ensure revisions for sites requiring Quality Assurance Agreements

  • Collaborated with cross-functional teams to negotiate and resolve quality issues effectively while applying risk management philosophy for business needs to successfully reduce the number of similar recurring quality issues

  • Monitored pest control, facility maintenance, equipment calibration to ensure conformity with company policies and GMP guidelines

  • Executed product holds and releases in line with quality deviation investigation processes

  • Initiated and facilitated the implementation of CAPA for non-conformances during audits, quality issues and customer complaint investigations, and conducted trending reports for CAPA Effectiveness Reviews

  • Master Production and Master Packaging documents and manufacturing batch records

  • Participated in Annual Product Quality Review (APQR)

  • Performed self-inspection audits 

Regulatory

  • Coordinate approval of GMP Document Agreement for DEL from foreign sites

  • Manage and perform activities related to the compilation of the Drug Establishment Licence submissions 

  • DEL entries, Respond to Health Canada DEL Queries

Audits

  • Prepared for external audits (Health Canada and FDA Audits) by ensuring the facility is compliant to result in successful audits
  • Enforced corrective actions and maintained documentation of audit records to ensure compliance with the regulations
  • Executed regular audits of the facility and ensured that the facility is compliant with Health Canada Health Products & Food Branch Inspectorate (HPFBI) GMP guidelines and FDA Regulations.

Technical Writing

  • Reviewed and audited batch records for release of top quality products as per GDP guidelines
  • Revised SOPs and Work Instructions to improve procedures utilized to ensure conformity with company policies and GMP guidelines.

Education

  • (2017) Completion: Graduate Certificate, Pharmaceutical Regulatory Affairs & Quality Operations, Seneca College at York University, Toronto Ontario
  • Honours Bachelor of Science, Biological Chemistry Specialist, University of Toronto, Toronto Ontario