This role is an important role for the Sharp UK quality department. The role of this post within the company will cover the joint responsibilities of audit and quality assurance.
The post holder will be expected to work confidently, in a team and independently, as and when required. The quality specialist has to develop a thorough understanding of company Standard Operating Procedures (SOP) and company Good Manufacturing Practice (GMP), and to maintain an impartial and objective overview when dealing with all proceedings.
To aid the flow of work and information between departments the post holder has to develop an understanding of the various departments working practices.
Duties and Responsibilities :
Ensuring the quality and standards of work produced by the company, are up to the company and the clients requirements and expectations
Ensuring all actions carried out follow the company’s standard operational procedures and keeps within the guidelines set out by the company’s good manufacturing practices
Providing help, advice and guidance to all departments on matters of GMP and company procedures
The accurate recording, collating, and processing of data and information within that passes through the quality department
Reporting to your manager all acts of non-compliance, issues of concern regarding GMP
Preparation / authorisation of change controls and deviations
Maintain and manage supplier corrective actions in relation to material / service issues reports
Provide investigations and reports of non-conformances and complaints
Maintain and manage CAPA system, providing monthly reports. Seek and assist the closures of CAPA’s
Perform Annual Quality Reviews
Designing and developing new and existing paperwork and procedures for internal use by the quality and / or other departments
Ensuring that the requirements of the company health and safety policy, and where applicable the medicines act are complied with
Maintaining, updating and developing the quality systems, practices and procedures
Assist in the management and maintenance of the QMS
Assist in the training of new and existing staff
QA experience within the pharma industry
Excellent attention to detail and organisational / planning skills.
Ability to self-manage, prioritise and work under pressure to tight deadlines.
Ability to communicate effectively with colleagues, participants and external stakeholders.
Ability to work effectively as part of a team.
Proficient in Microsoft Office, particularly Outlook, Word and Excel.
Experience in cGmp , ISO 13485 : 2016 and ISO 9001 : 2015
QA Auditor experience
This job spec is not exhaustive. It may be amended to meet the changing requirements of the organization at any time after discussion with the post holder.
There may be a requirement for occasional travel, sometimes outside of the UK
All employees are required to be aware of their responsibilities towards health and safety and the dignity at work of their colleagues in the workplace.