About Us
-
QPQuandary is the creation of Alex Hall.
Following a start in the food industry; Alex entered the Pharmaceutical industry in 1990, starting out in the analytical laboratories before moving into Quality Assurance, working with major pharma companies including Roche, Eli Lilly and Eisai.
Alex became a Qualified Person (QP) in 2000.
During her career Alex has supported the training and development of QPs both as a member of the Pharmaceutical Quality Group (PQG) committee and during her nine years as a QP Assessor for the Royal Society of Chemistry (RSC).
Since 2013 Alex has supported many QP trainees in achieving their goal of becoming Qualified Persons through working with course providers as a tutor on their QP modules and working directly with individuals, providing one on one and group mentoring.
Alex is passionate about the valued role the QP plays within an ever changing and complex pharmaceutical supply chain. Alex’s style is to encourage the candidate to take personal responsibility for development, providing a creative and stimulating atmosphere to get the best from them in a secure training environment. Alex has a talent for mentoring and explaining complex concepts in a simple manner.
Alex has a proven track record in providing a results orientated, person focused coaching programme. She looks beyond the hurdle of the QP viva and seeks to develop the candidate to be prepared to take on the challenges faced by all quality professionals in a changing pharmaceutical business environment and challenging regulatory landscape. This assists the candidate in becoming a key player in your organisation with the necessary technical and personal skills.
In addition, Alex has supported a variety of Pharmaceutical organisations as a Locum QP / QMS consultant, where she has provided a common sense approach to achieving compliant, efficient and cost effect quality systems.
-
Tanya joined the Pharmaceutical industry in 2005, and has worked with Global companies including GSK and Sanofi, as well as smaller, family-run businesses. She holds a BSc(hons) in Biomedical Sciences from the University of Hertfordshire.
At the start of her career, Tanya spent 8 years specializing in Microbiology QC and sterile manufacturing, including both aseptically filled and terminally sterilised products. Since moving into Quality Assurance in 2013, she has performed in Senior Quality roles- leading QA, QC and Regulatory Affairs.
Since becoming a Qualified Person in 2019 (with training and support from Alex!) Tanya has broadened her experience to include many other non-sterile dosage forms- including oral solid dose and liquid products.
Tanya has a passion for coaching and developing people, as well as a love for continuous improvement and remediation.
In her spare time, Tanya enjoys gardening, working on her camper van conversion, and she also runs the Essex Japanese Shiba Inu group.
-
Greg qualified as a pharmacist and completed a PhD prior to joining the pharmaceutical industry, where he worked for Wellcome, GlaxoWellcome and GlaxoSmithKline for 37 years.
Greg has vast experience in technical and leadership aspects of pharmaceutical development.
He is passionate about quality systems and quality culture and has played a leading role in public consultation on Regulatory Authority Data Integrity Guidance.
Outside of work Greg enjoys sport and revelled in the experience of bringing the two together whilst being seconded to the Anti-Doping Team as a Doping Control Station Manager for the London 2012 Olympic and Paralympic Games.
-
Mike is an experienced production and QA leader in a range of multinational operations including ex pat work in France and Brazil.
Dosage forms covered included solid and oral liquids, topicals, aerosols and sterile products. Auditing experience has been international covering UK, EU, N America Asia Pacific.
Mike has a particular interest in training and developing staff both those in his own team and for 18 years from across the pharmaceutical industry in Technical and Quality topics as well as behavioural aspects of Quality culture.
Mike has an interest in Psychotherapy and in coaching and mentoring individuals.
In his spare time Mike is involved in working with and breeding Therapy Dogs. He and his dog Maisie are keen walkers, runners and love to fly fish.
AREAS OF RECOGNISED TECHNICAL EXPERTISE IN THE TEAM INCLUDE:
Qualified Person Training and assessment process
Pharmaceutical Law
The role and duties of the Qualified Person
Pharmaceutical Quality Management Systems
Pharmaceutical Quality Risk Management
The manufacture and control of a wide range of pharmaceutical dosage forms
Formulation, process and packaging development
Biological / Advanced Therapy Medicinal Products
Management and distribution of Investigational Medicinal Products
Marketing Authorisation and Clinical Trial Authorisation Application support
Good Manufacturing & Good Distribution Practice
Good Clinical Practice
Continuous Improvement Tools
Technical writing – SOPs, Reports etc
Quality Risk Management
Quality Systems Design and Implementation / Remediation
AREAS OF RECOGNISED PERSONAL DEVELOPMENT EXPERTISE INCLUDE:
Coaching and Mentoring
Personal Development Planning
Management by Objectives
Presentation Skills
Problem Solving and Decision Making Tools
Root Cause Analysis
Leadership development
Quality Culture