About this role
Department: Quality Assurance
Reporting to: RA & QA Manager
Location: Crawley, UK
Working arrangement: Hybrid
The opportunity
To ensure the company operates within the guidelines of Good Manufacturing Practice (EU-GMP) and Good Distribution Practice (EU-GDP) and that products are manufactured, tested, released and distributed in accordance with the same guidelines.
Key Duties and Responsibilities
- To learn and gain a basic insight within the Quality department of Torrent Pharma UK Ltd on how the quality system is utilised to manage the business requirement.
- To provide support for the Quality Assurance department to ensure that processes and procedures are adhered to within the agreed time.
- To issue all SOP’s on time and ensure all training is completed before the SOP is made effective.
- To assist other members of the QA Team with administrative and research duties associated with their responsibilities.
- To act as Subject Matter Expert (SME) for administrative Subject Matters; to be determined based upon experience and skill set.
- To generate specific batch release checklists and complete variable data prior to QP and RPi review.
- To review temperature data for all batches during transit to ensure that the product was transported according to the registered storage conditions.
- To log all change controls and provide change control reference numbers to initiators.
- To approve and close all change controls relating to artwork where required.
- To complete customer verification checks on a monthly & quarterly basis and report any terminated/revoked/suspended customers to the relevant departments.
- To generate the QA departments KPI’s for which they are the SME, to be presented in the monthly management meeting.
- To carry out any other responsibilities within the Quality department if requested by their Line Manager.
Key Measures / KPIs
- To meet QA monthly KPIs for activities for which they are the SME.
- Timely assistance to members of the QA Team and our customers.
- To fully manage all artwork change controls they are accountable for and ensure all are completed within the set deadlines.
- To prepare all documentation and communication regarding their SME responsibilities against KPI’s and circulate to TPUK management within the set monthly deadlines.
What you'll bring
Knowledge & Experience
- Understanding of European GMP regulatory guidelines, regulations and procedures
- Knowledge of batch release processes
- Knowledge of GMP and GDP
- Knowledge of European Market Authorisation bodies, eg. MHRA, EMEA
- Knowledge of existing company product range and pipeline
- Good working knowledge of Microsoft Word
- Good working knowledge of Microsoft excel
- Supportive of team environment
Personal Skills
- Ability to manage conflicting priorities
- Excellent communication skills
- Strong interpersonal skills
- Accurate
- Methodical
- Attention to detail
- Proactive
Working at Torrent Pharma UK
Our work is guided by integrity, passion for excellence, participative decision making, concern for society and the environment, fairness with care, and transparency. We value people who put these principles into practice and contribute positively to our team.
Torrent Pharma Company Benefits
We are very proud to offer the following as part of your employment package:
- 25 days annual leave (in addition to public bank holidays), plus Length of Service Awards
- Private Medical Insurance – Vitality Healthcare
- Group Life Assurance
- Enhanced Employer Pension contribution of 5%
- Hybrid working
- Onsite parking
Interested in joining us?
If you're looking to develop your career in Quality Assurance within a collaborative pharmaceutical environment, we'd love to hear from you.
Apply today by submitting your CV through our online recruitment portal.
How we use your data
Please refer to our privacy notice on our website www.torrentpharma.co.uk for more information.