Open role
Graduate QMS Compliance Executive
- Aggregated by CV-Library
- Leicester, City of Leicester
- Contract
- Full Time
- £26,000 - £28,000 Per Annum
Job Description
Competitive Salary & Company Benefits| Ideally located close to Leicester
Monday to Friday, 9.00am - 5.00pm (potential for flexibility on start/end times based on 7.5hrs/day) Please note this is a 12-month FTC.
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 QMS Compliance Executive for our Quality department, to provide full administrative support for the Quality Control and Assurance activities of the company in relation to QMS 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 in these areas.
What will you be doing?
* QMS Compliance - maintenance of and compliance with the 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: staff training; documentation control; change control; non-conformance/deviations; validation; corrective and/or preventive actions; regulatory intelligence; internal audits; self-inspections; management review; monthly checks; licence variations; and launch activities for area.
* Operational Compliance – Release of product and credentials, as required.
* 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.
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)
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:
* 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
Monday to Friday, 9.00am - 5.00pm (potential for flexibility on start/end times based on 7.5hrs/day) Please note this is a 12-month FTC.
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 QMS Compliance Executive for our Quality department, to provide full administrative support for the Quality Control and Assurance activities of the company in relation to QMS 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 in these areas.
What will you be doing?
* QMS Compliance - maintenance of and compliance with the 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: staff training; documentation control; change control; non-conformance/deviations; validation; corrective and/or preventive actions; regulatory intelligence; internal audits; self-inspections; management review; monthly checks; licence variations; and launch activities for area.
* Operational Compliance – Release of product and credentials, as required.
* 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.
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)
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:
* 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