Key Responsibilities:
1. As a member of the Quality Assurance function, assess the implementation of the Pharmaceutical Quality System (PQS) requirements both internally and externally paying regards to customer expectations, GxP and Regulatory compliance.
2. Manage the centralized Quality Technical Agreement process and provide training when required.
3. Produce standardized templates for Quality Agreements across Clinigen sites.
4. Support Clinigen Intercompany project improvements and implementation.
5. Ensure Vendor/Supplier qualification is carried out as per approved centralized procedures and liaise with stakeholders.
6. Ensure the safety of the products and services provided by Clinigen are not compromised by non-compliant systems and that Senior Management are aware of any deficiencies in the Quality Systems or processes in use.
7. Support Client Audits and Competent Authority Inspections at Clinigen.
8. Author and review Quality Agreements with Vendors/Suppliers, Clients and Customers.
9. Assist with the management and maintenance of the Quality Management System.
10. Ensure that appropriate standards of Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) are maintained.
11. Support the development and implementation of regulatory and quality procedures.
12. Communicate relevant aspects of the quality system to employees, as necessary, in order to support product and service quality.
13. Assist in providing training to members of staff on relevant components of Quality Management.
14. Contribute to continual improvement by formulating reports, trending and data analysis.
15. Make decisions, solve problems and influence others, as necessary, in order to achieve the above responsibilities.
16. Act as a Subject Matter Expert (SME) for Quality Agreements and Vendor/Supplier qualification.
Additional Duties:
1. Manage and participate in projects to implement new or improve existing Quality systems in response to feedback from the internal audits, the business, clients or regulatory bodies.
2. Support the Qualified Persons, Responsible Persons or equivalent with respect to their duties.
3. Deal with enquiries promptly and with due diligence.
The list of duties is not intended to be exhaustive but gives a general indication of the tasks involved. It is the nature of the company that tasks, and responsibilities are, in many circumstances, unpredictable and varied. All employees are, therefore, expected to work in a flexible way when the occasion arises and acknowledge that tasks not specifically covered in their job description are not excluded.
Health and Safety Responsibilities:
The Management of Health and Safety at Work Regulations 1992 re-enacts the Health and Safety at Work etc. Act 1974, which places responsibilities on the employer and employees alike. In connection to this, the Company reminds employees of their duties under Section 7 of the act:
* To take care for their own health and safety and that of others who may be affected by their acts or omissions.
* To carry out assigned tasks and duties in a safe manner, in accordance with instructions, and to comply with safety rules/procedures, regulations and codes of practice.
* If aware of any unsafe practice or condition, or if in any doubt about the safety of any situation, consult their Line Manager.
* To report any accident, near-miss, dangerous occurrence or dangerous condition to their Line Manager.
General Responsibilities:
1. Champion the Clinigen Way principles which underpin everything we do, living those values in daily Clinigen life.
2. Know Clinigen’s strategy and ensure what you do on a day-to-day basis is in line with those strategic objectives.
3. Ensure the work you do is of high quality and that Clinigen standards, procedures and policies are followed at all times.
4. Engage in personal professional development and attend mandatory training.
5. Present the Company in a positive way at all times with internal and external clients, customers and staff.
6. Comply with the Company’s HR policies and the Health and Safety policy at all times.
7. Work flexibly and efficiently in order to meet internal and external customer needs, whilst maintaining the highest possible professional standards.
8. Bring new ideas and approaches with an open mind.
9. Maintain confidentiality and security at all times.
Minimum Requirements:
* Life Science degree or equivalent.
* Experience within the pharmaceutical industry.
* A strong working knowledge of GMP and GDP.
* Knowledge of Unlicensed Medicines (Specials).
* Proven ability of accurate and timely completion of tasks.
* Adaptable to changing situations, with a proactive positive, flexible, assertive, can-do attitude.
* Good influencing and stakeholder management skills.
* Strong written and verbal communication skills.
* Able to clearly communicate plans and results, promoting ownership and encouraging a collaborative approach to achieve solutions.
* Able to prioritise effectively.
* Ability to work with tight deadlines in a dynamic environment, delivering high quality outputs with strong attention to detail.
Benefits:
* 27 days holiday plus 8 bank holidays.
* Pension contributions 4.5% matched.
* Life assurance 4 x annual salary.
* Flexible Benefits Platform with £25/month Company contribution.
* Annual salary review.
* Independent financial advice service.
* Enhanced Employee Assistance Programme.
* Shopping discounts with retailers.
* Long service awards.
* Recognition scheme & employee of the year awards.
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