Operational Compliance Executive
Competitive Salary & Company Benefits| Ideally located close to Petersfield or Leicestershire
Monday to Friday, 9.00am - 5.00pm (potential for flexibility on start/end times based on 7.5hrs/day)
Are you looking to work for a rapidly growing UK Pharmaceutical company, who are passionate about improving patients’ lives across the world?
Aspire Pharma is an asset-light pharmaceutical manufacturer. It licenses and develops niche pharmaceutical products that offer innovative formulations, value for money for payors, and reliable supply arrangements in markets which are often underserved. The business has a highly diversified portfolio of more than 250 products across a number of categories, including branded specialty products and unbranded niche generics in therapeutic areas such as urology, ophthalmology, CNS and dermatology.
Do you want to be part of the journey?
If so, here is your chance!
The Role
We are currently looking to recruit a Operational Compliance Executive for our Quality department. In this role, you will provide full administrative support for the Quality Control and Assurance activities of the company in relation to Operational Compliance.
What will you be doing?
As an Operational Compliance Executive, you will be responsible for ensuring continued compliant supply of products and compliance with Aspire Pharma Limited Group’s Irish/EU and UK GXP/ISO 9001/ISO 13485/ISO 14971 QMS, where Irish/EU and UK GXP covers all UK and EU GXP guidelines including: approval of sample requests; day to day Tracelink activities; making stock available for sale and batch release for medical devices; ensuring launch activities are carried out in a timely manner; assessing and investigating returns, temperature excursions and thefts and losses for ambient stock, excluding cold chain/controlled drugs; assisting in the management of Recalls/FSCAs/FSNs investigations; review of Bona Fides including and Non-compliance report checks and suspension/termination list checks; author of controlled documentation (e.g., SOPs, Work Instructions etc.), non-conformance/deviations, CAPAs and change controls related to area.
The Person
Written and spoken English with good Communication Skills
Time Management Skills
Good Attention to Detail
Proactive Team Player
Proficient in MS Office (including, word, excel and outlook)
Proficient in Q Pulse or other electronic QMS (desirable)
Science Graduate
Not essential (1-3 years desirable)
Why join us?
As well as a fantastic, inclusive company culture, where employees are truly valued and a competitive salary, we also offer an ever-improving benefits scheme to support your physical and mental well-being which include:
Generous Pension Scheme.
Life Assurance cover and Employee Assistance Program.
25 days’ holiday plus Bank Holidays.
Learning and Development opportunities.
Excellent opportunities for progression.
Fantastic Company events and celebrations throughout the year.
- Department
- Quality
- Locations
- Leicester or Petersfield, UK
About Aspire Pharma
Aspire Pharma supplies a range of pharmaceuticals and medical devices, both prescribed and over the counter (OTC). Our products are carefully selected to deliver value and differentiation to both patients and prescribers. Our focus is on extending Aspire's portfolio of innovative products in the UK and globally, for the long-term benefit of patients, partners and customers.
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