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 an Operational Compliance Executive for our Quality department, to provide full administrative support for the Quality Control and Assurance activities of the company in relation to Operational Compliance. Tasks and responsibilities listed are all possible tasks and responsibilities, as updated, it is identified that some of these tasks will only be undertaken when the job holder is formally trained. 

Responsibilities

What will you be doing?

• Operational Compliance – 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 referenced in APL’s Quality Site Master File/Quality Manual (SMF/QM001), including: approval of sample requests; day to day Tracelink activities; making stock available for sale (e.g., RPi checks) and batch release for medical devices where Aspire Pharma Limited is the Legal Manufacturer; ensuring Quality actions for 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.

• Regulatory Compliance - Maintaining awareness of existing and new legislation/guidance relating to Irish/EU and UK GXP (including GMP, GDP, GVP and GCP) as referenced in SMF/QM001 for medicinal products; Medical Devices including all ISO activities relevant to medical devices including ISO 9001, ISO 13485 and ISO 14971; Unlicensed Medicines (including Specials and Exempt Medicinal Products); Controlled Drugs; Nutritional Products; and General Data Protection Regulations and the UK Data Protection Act. Implementing changes across the department/business to remain compliant with the required legislation/guidance.

 

• Internal and External Liaison – Communicating effectively within Aspire Pharma Limited and with vendors and customers to: facilitate timely implementation of changes to legislation/standards/guidance; investigation of non-conformances and deviations/CAPAs; timely launch of new products; and update/implementation of procedures.  

Requirements

The Person
Knowledge & Skills 

• 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)

Experience & Qualification 

• Science graduate
• Not essential (1-3 years desirable)

Benefits

Why Join Us?
Here at Aspire we offer our employees a range of benefits, including, but not limited to: 

• 25 days’ holiday plus Bank Holidays. 
• 2 Corporate Social Responsibility (CSR) days per year.
• Company Bonus Scheme.
• Life Assurance cover of 4 x annual salary.
• Pension scheme.
• Employee Assistance Program. 
• Learning and Development opportunities
• Excellent opportunities for progression due to the recent expansion of our company.