MP

Open to opportunities

Monali Patel

@monalipatel

Quality and Regulatory leader driving GMP compliance, sterile manufacturing assurance, and WHO/PPB submissions.

What I'm looking for

I’m looking to lead quality and regulatory work in pharmaceutical manufacturing—especially sterile facilities—by strengthening GMP compliance, validation, and lifecycle management while collaborating with regulators, WHO programs, and cross-functional teams.

I’m a Registered Pharmacist in Kenya with 10+ years of experience in Regulatory Affairs, Quality Assurance, and pharmaceutical manufacturing, specializing in sterile facility compliance. I bring strong knowledge of WHO TRS, ICH, USFDA, and EMA guidelines, and I lead dossier preparation, WHO PQ submission, GMP audits, and pharmaceutical product lifecycle management.

In my current role as Head of Quality Unit and Authorized Person, I’ve driven eCTD dossier work (including a successful WHO PQ dossier for Tranexamic Acid Injection), built validation strategy from the Validation Master Plan through aseptic processing and cleanroom qualification, and strengthened contamination control through deviation investigations and CAPAs. I also oversee pharmacovigilance, complaints, recalls, and post-marketing surveillance, contribute to the UNIDO GMP Roadmap for Kenya, and support teams through technical leadership, audits, and capacity building alongside national regulators, WHO, and donor-driven programs.

Experience

Work history, roles, and key accomplishments

TL

Current

Head of Quality Unit

Current

Tasa Pharma Ltd

Jan 2021 - Present (5 years 7 months)

Leads QA and regulatory affairs operations in a sterile manufacturing facility, including eCTD dossier preparation and a successful WHO PQ dossier for Tranexamic Acid Injection (2024). Oversees validation planning, SOP management, deviation/CAPA handling, pharmacovigilance activities, and GMP audits.

Quality Assurance Regulatory Affairs GMP WHO PQ Dossier Aseptic Processing Sterilization SOP Management Deviations CAPA Contamination Control Pharmacovigilance Post Marketing Surveillance Pharma GMP Auditing

SL

Company Pharmacist

Syner-Med Pharmaceuticals (K) Ltd

Jun 2015 - Jun 2020 (5 years)

Managed PPB-related regulatory submissions and product registrations while serving as pharmacovigilance focal point. Supported ISO 9001:2008 audits and regulatory inspections, and prepared tenders for institutional clients.

Regulatory Submissions Product Registrations Pharmacovigilance ISO 9001 Regulatory Inspections Customer Audits

DL

Product Development Exec

Dawa Ltd

Jun 2013 - May 2015 (1 year 11 months)

Led formulation development, literature/patent searches, and stability studies, contributing to improved dissolution profiles for key products. Developed multiple dosage forms including tablets, capsules, syrups, liquids, and veterinary products.

Formulation Development Literature And Patent Searches Dosage Forms Tablet Capsule Syrups Liquid Veterinary Product Development

Education

Degrees, certifications, and relevant coursework

GU

Gujarat Technical University

Master of Pharmacy, Industrial Pharmacy

2012 - 2014

Completed a Master of Pharmacy in Industrial Pharmacy at Gujarat Technical University between 2012 and 2014.

SU

Saurashtra University

Bachelor of Pharmacy, Pharmacy

2007 - 2011

Earned a Bachelor of Pharmacy from Saurashtra University from 2007 to 2011.

NS

New English School

Secondary School, Secondary Education

Completed secondary education at New English School in Nadiad, India.

Tech stack

Software and tools used professionally

Ema

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