Quality Assurance Manager Job in Gillingham SP8 4XT, South West UK
Quality Assurance Manager
Based: Dorset
Salary: 45-52K Dependant on experience + Bonus + Pension + Life Insurance + Car + Healthcare + Relocation
My client is ranked in the World’s Top 10 Fine Chemical Companies with revenues of $647 million. They are a growing business providing a wide range of products and services for pharmaceutical and biopharmaceutical companies to develop and commercialise small-molecule APIs and biologic drug products.
Having significantly expanded their contract manufacturing services over the past 5 years through major investment and acquisitions. They are in an exciting phase in their history and are poised for further significant growth.
The Quality Assurance Manager is responsible for the development, implementation and maintenance of quality system standards, and documentation and training of staff in order to ensure compliance with the requirements of quality standards including the expectations of pharmaceutical, industrial, and research customers, as well as complying with the relevant standards of international regulatory authorities.
The Role:
· Coming from a background in fine chemical manufacturing or Active Pharmaceuticals Ingredients you will take responsibility to ensure a level of Quality Assurance that satisfies market, product, and customer requirements, as well as current U.S. FDA, EMEA and MHRA standards
· You will audit the Quality System in order to ensure quality compliance, including managing corrective actions to ensure that corrective and preventive actions (CAPA) are implemented.
· Manage customer complaints related to products and services and respond to customer queries and requests pertaining to quality issues.
· Ensure that the Company Quality, Environmental and HS policies are applied at all levels, and develop all necessary training programmes and records.
· Provide leadership, information, instruction and training on the Quality System, cGMP and other relevant quality requirements and manage all regulatory and customer Quality facility audits.
· You will have a wide and challenging remit that will include overseeing PL, manufacturing, chemical and analytical development, quality control, health safety, as well as playing a key outward- facing role in customer relationship management.
The Requirements:
· Degree in Biological or Chemical Science
· Highly developed people management skills: recruitment selection, training and development; performance optimization, discipline.
· Proven track record in project management.
· Ability to cast vision, lead, motivate and influence others to achieve regulatory objectives;
· Mature judgment and decision-making ability, together with flexible approach to work,
· Highly committed, with ability to combine innovation with management of day-to-day operations.
To find out more information please contact Kirsty Fenella Smith at Langton Howarth www.langtonhowarth.co.uk– kirsty@langtonhowarth.com +44(0) 113 243 3499 / +44(0)7969 166 123 Please include a cover letter as to why you feel you are suitable for the role and your salary expectations.
API, Active Pharmaceutical Ingredients, Pharmaceuticals, small-molecule APIs, biologic drug products, Quality Assurance, MHRA, FDA, QA, QC, Regulatory, Health Safety,