The QA Assistant is an integral role within the business ensuring that all guidelines on Good Distribution Practice (GDP) and the applicable areas of Good Manufacturing Practice are complied with.
Non-Exhaustive List of Duties and Responsibilities:
The aim of any job description is to increase understanding of what a job entails by describing its key elements. It is not meant to be exhaustive
Job duties and responsibilities change over time however and a job description is only a ‘current’ view of what is required by the business in order to retain its place in the market.
- Liaise with Medicines and Healthcare products Regulatory Agency (MHRA) and Home Office
- Assist with the management of the QMS.
- Support the bona fide program.
- Proofreading artwork and ordering repacking components when required,
- Complete six-monthly compliance checks on all active products
- Ensure the guidelines on GDP and the applicable GMP guidelines for medicinal products for human use are adhered to.
- Assist in the maintenance of Standard Operating Procedures, associated forms and other GDP related documents.
- Assist with day-to-day regulatory tasks, such as assisting with complaints, recalls, requalification of customer/supplier/third-party accounts, raising CAPAs/Deviations, Risk Assessments, Change Controls and Self-Inspections.
- Attend and contribute to Team meetings and assist with determination of project requirements
- Keep the Quality & Regulatory Manager/Responsible Person informed about any issues that may impact any company relations.
- Ability to work well within strict deadlines, working in a fast-paced environment which demands change at short notice and the need to obtain results within tight timescales.
- Communicate ideas for improving company processes with a positive and constructive attitude
- Shakespeare Pharma Ltd are a growing and developing company within this sector. This will allow the opportunity for the successful candidate to grow and develop within the business and allow the successful candidate the opportunity to help shape the future of Shakespeare Pharma Ltd
Role related knowledge, skills, behaviours, qualifications and experience required:
- Educated to degree level (or equivalent)
- Attention to detail and due diligence
- Experience of working in a commercial organisation
- Experience of working with MS office packages (e.g. Word, Excel, PowerPoint, Outlook)
- Experience working in administrative role
- Experience working in GDP environment
- Being responsive to the priorities and demands of the business to ensure excellent customer service both internally and externally
Can do attitude
- Capable of forming positive relationships with external organisations
- Strives to continuously improve quality of service provided
- Effectively using the knowledge, experience and skills of the team to maximize business potential
- Be an active participant in developing a positive working environment
- Dynamic and highly self-motivated
- Prioritising work load based on the conflicting demands of the business
- Excellent verbal and written communication skills
- Have an open and honest approach
- Self-motivated and able to work using own initiative
- Decision making
- Seeks ways to continuously learn and develop
- Adapts positively to change
- Adopting a flexible approach; be willing to rise to a challenge
- Ability to accept when something doesn’t work and move on
- Resilience in handling conflict
- Handles pressures of meeting targets and deadlines
Application deadline: 31st August 2021
Expected Start Date: 1st October 2021
Job Types: Full-time, Permanent
Salary: Up to £23,000.00 per year