Munir Shaikh

Pharmacist Assistant @ Greenbrook Pharmacy and Health Foods

About

Highly motivated and detail-oriented Pharmaceutical Production Professional with over 9 years of experience in sterile manufacturing, aseptic processing, and regulatory compliance. Proven track record of ensuring GMP compliance, optimizing production processes, driving quality improvements, and successfully qualifying facilities for major regulatory audits (MHRA, WHO, USFDA, EU GMP). I hold a Bachelor's degree in Pharmacy and Canadian post-graduate credentials in Project Management and Regulatory Affairs. I have successfully executed high-speed automated facility projects for small-volume parenteral (ampoules) and contributed extensively to quality system improvements and contamination control strategies. Key Expertise: • Sterile Operations Projects (Equipment Qualification, FAT, SAT, Capacity Utilization. • Aseptic Processing, Media Fill Simulations, Dry and Moist Heat Sterilization. • Good Manufacturing Practices (GMP), Good Documentation Practices (GDP), Data Integrity (ALCOA) • Quality Risk Management (ICH Q9), Audit Observations, CAPA, Validation and Compliance • Regulatory Standards: EU GMP Annex 1, USFDA Sterile Guidelines, Health Canada, CFR, PDA Technical Reports Certified as an Internal Auditor and recognized with a Star Employee Award for outstanding contribution during the MHRA audit and successful implementation of a Contamination Control Strategy. Proficient in SAP, TrackWise, Caliber QAMS, EDMS, LMS, and Minitab, with strong skills in technical documentation, process optimization, and audit readiness. Currently open to opportunities in Pharmaceutical, Biopharmaceutical, Medical Device Production, Quality Assurance, and Regulatory Compliance roles.

Country

Canada

City

Cambridge

Industry

Pharmaceuticals

Skill

Oral Communication, Laboratory Skills, Analytical Skills, Document Review, Regulatory Submissions, Clinical Trials, Risk Management, Compounding, Retail, Pharmacy Practice, Prescription, Minitab, Data Integrity, 5 Why, Ishikawa, Failure Mode and Effects Analysis (FMEA), CFR, U.S. Food and Drug Administration (FDA), ICH, PDA

Experience

Pharmacist Assistant

Greenbrook Pharmacy and Health Foods

2024-3 - Present · 2 yrs 7 mos

Kitchener, Ontario, Canada

Accurately dispensed and compounded Level C and non-sterile medications (capsules, creams, lotions, rectal rockets and suppositories) as per CoA in compliance with NAPRA ANORP safety and regulatory standards. Perform risk assessments and develop SOPs for compounding and equipment cleaning. Operate PharmaClik software for prescription processing, insurance billing, and patient data management.

Senior Executive

SOVEREIGN PHARMA (P) LTD.

2021-7 - 2023-4 · 1 yr 10 mos

Daman and Diu, India

Executed daily production planning and GMP document review in sterile injectable manufacturing. Led Aseptic processing, Media fill validations, Process validations and audit trail reviews. Supervised 40+ personnel while maintaining productivity, compliance, and documentation standards. Performed Cleaning Validation, Hold Time studies, Sampling, and Equipment Calibration. Managed production metrics and reports in SAP (Plan vs Actual), Machine utilization, Breakdown reports. Investigated deviations using 5 Whys, Fishbone Diagram, and Genchi Genbutsu approach. Handled CAPA, deviations, and change controls in Caliber QAMS. Participated in internal audits and represented production during regulatory and client inspections. Carrying out the Risk Assessment and performing GAP analysis in view of the Contamination Control Strategy. Reviewed Annual Product Quality Review (APQRs), OOS Phase II investigations, Validation documents, Critical Process Parameters (CPPs), and Critical Quality Attributes (CQAs.

Senior Executive in Production QMS

SUN PHARMA

2020-10 - 2021-2 · 5 mos

Halol, Gujarat, India

Handled change control, deviation and CAPA in Track wise system. Carrying out the investigation, risk assessment, and GAP assessment. Audit compliance and report review. Tracking and implementation of CAPA and its effectiveness monitoring. Preparation, Revision and Review of SOP’s in EDMS.

Production Executive

SOVEREIGN PHARMA (P) LTD.

2013-7 - 2020-10 · 7 yrs 4 mos

Daman & Diu

Played a key role in a high-speed sterile production line project, leading equipment selection, vendor qualification, FAT and SAT execution. Executed IQ/OQ/PQ of sterile manufacturing equipment, including Ampoule washing filling/sealing machines (RABS), Sterilizers (autoclave/tunnel), Manufacturing tank and Visual Inspection Machine. Performed HVAC and water system qualifications (PW, WFI, Pure steam), and monitored batch-wise manufacturing (CIP/SIP). Handled full-spectrum production activities: dispensing, manufacturing, packaging, and line clearance. Managed documentation including BMRS, BPRS, logbooks, and SOPS through Caliber DMS. Executed departmental training sessions and maintained training records in compliance with regulatory standards