Job purpose
We are looking for a responsible QMS Support Officer to perform a variety of quality and administration activities to support the production department, with a focus on co-ordinating with Quality counterparts including field (shop floor) Quality persons where appropriate.
Key responsibilities and accountabilities
* Update of SOPs, forms and records to comply with current business systems
* Monitor and report on status of Production owned QMS records
* Undertake ownership of QMS records as required e.g. action items
* Co-ordinate with field Quality personnel on above activities
* Manage submission of Production documentation for archiving
* Administration and checking of balance calibration data
* Assist in the preparation of batch documentation
* Provide support with production related SAP transactions
* Colate and present monthly KPIs
* Administer departmental capacity plan
* Manage production purchase requisitions
* Adhere to cGMP guidelines and principles
Person profile – QMS Support Officer
Personality: Motivated individual with a positive outlook, and a clear focus on delivering a quality product. Can critically assess own performance and contribute to determining own development needs. Good communicator who is comfortable dealing and communicating with all people of all levels. Reliable, tolerant, and determined. Able to get on with others and be a team player, but is equally comfortable working independently and unsupervised.
Personal Situation: Able to work extended hours on occasions when required.
Specific Job Skills
* Experience of working within a cGMP environment
* Experience of working with a QMS system
Required
* Experience of SAP and DMS
* Strong proficiency in MS Office (Excel, Word, Outlook)
* Accurate and consistent data recording skills
* Able to communicate well and in a timely manner with all levels
* Experience of working in a regulated production environment
* Understanding of GMP
* Understanding of H&S principals
Computer skills
Must have basic skills
Literacy and Numeracy
Able to record information legibly, accurately and in compliance with cGMP standards in a concise and unambiguous manner. Must be proficient in formatting of documents.
Business Skills
Must understand the need for keeping production process flowing with due regard to regulatory and quality constraints
Please note – only applicants with a permanent Right to Work in the UK will be considered.
NextPharma is an equal opportunities employer and positively encourages applications from suitably qualified and eligible candidates regardless of sex, race, disability, age, sexual orientation, marriage or civil partnership, pregnancy or maternity, religion or belief.
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