PLEASE APPLY BY EMAILING HR@ALLIANCEPHARMA.CO.UK OR THE CV SUBMIT FORM
Contract type: Full time
Location: United Kingdom
Date listed: 29.03.2018
Job ref: 004-52
This is an excellent opportunity for a motivated individual looking to expand their knowledge of the pharmaceutical industry in a growing company looking to develop skilled individuals.
Due to ongoing expansion and streamlining of processes through implementation of common IT platforms to support the GxP and regulatory authority requirements for the production, marketing and distribution of Alliance products a Quality Officer is needed to support Alliance’s growth strategy.
The post holder will report to the Quality Manager and will help support Computer Systems implementation and validation throughout Alliance.In addition to the CSV activities, the Quality Officer will support management of 3rd party suppliers with respect to qualification and monitoring within the supplier assurance process.
The emphasis will be on providing quality oversight and guidance to all functions within Alliance and 3rd party suppliers to ensure that our products are compliant with applicable regulations and obligations outlined in the Quality Technical Agreement.
This is a fast-paced environment with multiple projects on the go at once and requires a dynamic, flexible and resourceful individual.
To ensure the Alliance business operates in compliance with our QMS and our supply chain operations comply with relevant Quality Standards.
Key Accountabilities of the position are:
Essential Technical Skills:
- Supports Alliance’s CSV processes by:
- Generating, reviewing and executing CSV documentation
- Maintaining Site VMP and requalification schedule
- Representing Quality (CSV) on new initiatives
- Supports Alliance’s QMS by:
- Maintain, support and improve the QMS
- Promote continuous improvement
- Reviewing non-conformances & CAPA
- Reviewing product quality investigations
- Perform self-inspections in line with schedule
- Supports product quality complaint process by:
- Logging and performing initial assessment of product quality complaints
- Liaising with 3rd party suppliers
- Investigating product quality complaints in conjunction with 3rd party suppliers
- Reviewing 3rd party supplier investigations
- Reviewing and assessing complaint investigations
- Supports external supplier audit and qualification by:
- Scheduling and arranging audits by Alliance Personnel
- Maintaining oversight of audit schedule
- Ensuring progression of audit reporting and actions
- Generating reports on the performance of Alliance’s QMS against defined performance measures and key KPIs.
- Maintenance of Supplier related schedules and review of documentation associated with e.g. Audits, PQRs, QTAs, etc.
- Liaise with suppliers to ensure Quality Agreements & Product Quality Reviews are received and reviewed in line with the agreed schedule
- Supports all critical quality issues e.g. complaints, recalls, FSNs, stability failures, etc, ensuring investigations are correctly executed
- Support inspections by competent authorities, notified bodies and customers.
- Ensures the Quality Manager is informed of major/ critical issues that may have an adverse effect on product quality or compliance.
- Maintains Quality SOPs, ensuring processes are complaint with current expectations and regulatory requirements.
- Review of local SOPs associated with processes employed by Alliance
- Support the delivery of Quality’s and Alliance’s objectives
- Provide advice and training on all quality related matters including but not limited to GMP, ISO standards and validation
Desired Skills/Knowledge required
- The job requires a sound understanding and knowledge of GMP, the legal and routine duties of the QP and RP and the role of the manufacturing and marketing authorisations.
- The job holder will be required to have understanding of computer systems validation and associate standards.
- The job holder will be required to have understanding of manufacturing and packing processes and be able to make sound judgement and recommendations relating to the manufacture of pharmaceutical products including medical devices.
- The job holder will be expected to interact and communicate within the local site, throughout the Alliance Business Units and engage with suppliers in a competent and professional manner.
- A degree or equivalent in a scientific discipline is preferred with experience in a Quality environment in the pharmaceutical industry.
- Strong communication skills are essential.
- The ability to introduce, co-ordinate, complete and report on projects.
- A high level of self-motivation is necessary.
- Attention to detail
- Able to rationally persuade
- Influencing skills
- Ability to perform internal audits
- Experienced in the use of Electronic QMS systems
- 3 – 5 years’ experience in a Quality Assurance role at a medicinal product manufacturer
- Experience of:
- EUDRALEX Volume 4 - Annex 11 European Regulations on Medicinal Product for Human and Veterinary Use: Good Manufacturing Practice. Annex pertaining to Computer Systems. (June 2011)
- 21 CFR Part 11 - Code of Federal Regulations (CFR): Electronic Records; Electronic Signatures
- Experience in external auditing of contract manufacturers and / or suppliers
- Experienced with ISO 13485 QMS and quality assurance of medical devices
- Experienced with quality assurance of cosmetics and food supplements
- Analytical, reviews trends and pre-empts future issues.