At a Glance
- Tasks: Support Quality Control and Assurance activities to ensure operational compliance.
- Company: Join a rapidly growing UK pharmaceutical company dedicated to improving patients' lives.
- Benefits: Competitive salary, 25 days holiday, private healthcare, and a supportive work culture.
- Other info: Great opportunities for career progression and personal development.
- Why this job: Be part of a mission-driven team making a real impact in the pharmaceutical industry.
- Qualifications: Science graduate preferred; strong communication and time management skills required.
The predicted salary is between 44595 - 54505 £ per year.
Competitive Salary & Company Benefits. Ideally located close to Leicester, Dublin, or Petersfield. 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.
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:
- 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.
- 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 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).
- 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.
Why join us?
- Fantastic, inclusive company culture, where employees are truly valued.
- Competitive salary.
- Ever-improving benefits scheme to support your physical and mental well-being.
- Company 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.
- Cycle to Work Scheme.
- Private healthcare schemes.
Operational Compliance Executive in Leicester employer: Aspire Pharma Ltd
Aspire Pharma Ltd. is an excellent employer for those looking to make a significant impact in the field of clinical research. With a strong commitment to employee well-being, we offer competitive salaries, private healthcare, and a robust pension scheme, all within a collaborative and dynamic work culture that fosters professional growth and development. Join us in a role that not only challenges you but also contributes to meaningful advancements in healthcare.
