Gaynor MollaneyGaynor is a quality professional and has had a successful career in the pharmaceutical industry for varied companies within quality control and quality assurance for the past 30 years. Her path has also taken her into the medical devices sector.

Gaynor started her career in 1987 as an analytical chemist and became senior chemist where she was responsible for training in analytical techniques, testing excipients, testing API and various products such as ointments, creams, suppositories, tablets, capsules, and sterile preparations using various analytical techniques.

In 1995 she became part of the microbiology team and was responsible for training, environmental monitoring, product testing, endotoxins, sterility testing and also involved with the approval of production sterilisation and validation activities.

Gaynor embarked on her career as a QP in 1997 and during that time joined the technical group in production supporting technical issues, auditing, validation and product transfers; she qualified as QP in 2000.

Since that time she has performed many roles for various companies which finally placed her in the position of Quality Director responsible for QC and QA. She has been directly engaged with inspection authorities including MHRA, FDA CDER and FDA CDRH, and inspection bodies for ISO 13485 accreditation and ISO accreditation

In 2010 Gaynor set up her own company to further support the pharmaceutical and medical device sectors which includes QP certification, PQS initiation and improvements, auditing, management and training.

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