Qms Compliance Executive

3 months ago


Loughborough, United Kingdom Aspire Pharma Full time

Competitive Salary & Company Benefits| Loughborough

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**

To provide full administrative support for the Quality Control and Assurance activities of the company in relation to QMS Compliance. To maintain awareness of existing and new legislation/ guidance relating to EU and UK GXP for medicinal products and medical devices including all ISO activities relevant to medical devices including ISO 9001, ISO 13485 and ISO 14971; Controlled Drugs; Nutritional Products; and General Data Protection Regulations and the UK Data Protection Act.

**What will you be doing?**
- Maintaining Aspire Pharma Limited’s EU and UK GXP/ISO 9001/ISO 13485/ISO 14971 QMS, including:

- Staff training.
- Documentation control.
- Change control.
- Non-conformance/deviations.
- Validation.
- Corrective and/or preventive actions.
- Regulatory intelligence.
- Internal audits/self-inspections.
- Management review.
- Monthly performance checks.
- Licence variations.
- Launch activities.

**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 Adobe Acrobat and electronic signature (desirable).
- Proficient in Q Pulse or other electronic QMS (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 Assistant Program.
- 25 days’ holiday plus Bank Holidays.
- Learning and Development opportunities.
- Excellent opportunities for progression.
- Fantastic Company events and celebrations throughout the year.



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