Crawley, England, United Kingdom of Great Britain and Northern Ireland
Full Time
2 hours ago
No Sponsorship
Key skills
Communication
About this role
Role Overview
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.
Requirements
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
Ability to manage conflicting priorities
Excellent communication skills
Strong interpersonal skills
Accurate
Methodical
Attention to detail
Proactive
Benefits
25 days annual leave (in addition to public bank holidays), plus Length of Service Awards