QA Specialist QP - Oudewater
|Publication date:||March 25 2020|
Function Group: Quality/RA / QP
For an international pharmaceutical company specialised in the development, production and marketing of high-quality veterinary products, we are looking for a QA Specialist / Manager / QP. Their veterinary medicines and animal nutrition are mainly sold to veterinarians. They are active in 45 countries worldwide, with their own sales organisation in 19 different European countries. They are a growing organisation that emphasises the desire to make a difference within a pleasant working culture. Because of their medium size, they are able to respond quickly to changes and decisions are made quickly without losing sight of personal attention. At the same time, they are large enough to be able to offer their customers a full range, technical product knowledge and supporting service material. Because of the growing team, they are looking for Quality Specialist / Manager / QP.
The purpose of this role is the development and realisation of an integrated Quality Management System (QMS) and Quality Policy for the organisation in order to assure processes are compliant with current GMP/GDP regulations (as applicable). Furthermore, you will set Quality expectations from the CMO network, to support the audit processes and challenges faced by these organisations using a partnership approach. Ensure the impact of quality within the supply chain is communicated effectively to key stakeholders within the wider business. You will provide GMP, Regulatory compliance, quality and on-time delivery of the CMO portfolio of products to the organisation. Your main responsibility is to develop and manage the Pharmaceutical Quality System (PQS) covering both site processes and CMO management activities.
The main responsibilities and core tasks are:
- To confirm the quality expectations from the CMO network demonstrating maturity, integrity experience and knowledge of subject
- To support group quality CMO management in the definition, development, implementation and ongoing review of appropriate Key Performance Indicators (KPI’s) for senior management and monitor effectiveness, across external CMO sites
- To review the PQS currently in operation at the site and work with the site and group quality to develop the PQS needed to manage CMO’s and operate in accordance with EU GDP requirements
- As the site quality lead to work with the CMO network and key organisation stakeholders such as the supplier relationship management, technical services, product development and/or regulatory affairs on product quality reviews, quality technical agreements, audits, validation, technology transfers, recalls, complaints, deviations and change controls
- To ensure that EU GDP requirements are defined and embedded in the site logistics and supply chain activities
- To ensure that actions are taken in a consistent, fair way with direct and indirect reports according to people policies as per local requirements, such as, but not limited to, as absence, performance, talent management and recruitment
- Ensure effective cross functional communication to ensure timely identification and resolution of issues
- To report and create action plans, as necessary on changes in standards (internally and externally initiated) and on performance against standards.
- To liaise with customers and suppliers with respect to quality aspects in supporting existing business and new product introductions to CMO network
- To provide feedback on quality performance and quality KPIs at the appropriate forums.
- To support and plan for CMO, supplier, regulator and customer audits
- To cooperate with other departments in order to achieve an acceptable quality level and provide guidance on how to execute their tasks and responsibilities in line with EU GMP requirements
- Maintain oversight on status of the PQS and the progress of implementation of improvement activities.
- To ensure situations with the potential to compromise quality are highlighted and addressed in order to assure measures for improvement and issue prevention are undertaken
- To plan Quality related activities and indicate the priorities
- Manage the review, improve and approval of change requests, corrective & preventative actions and investigations
- Assure adequate staffing of the QA department
- Manage the review and approval of CMO production protocols
- To assure the implementation and maintenance of regulatory requirements and changes in existing regulatory requirements for the site
- To manage/write/authorise technical Quality Agreement for suppliers and contract manufacturing organisations
- Responsible for the approval of suppliers and contract manufacturing organisations
- Responsible for the site GMP / GDP training program to assure staff is properly trained for their tasks
- Assure quality oversight of hygiene, validation and training
- Responsible for ensuing GMP documents and retain samples are archived in line with EU GMP requirements
- Responsible for the execution of internal audits
- Maintain the site accreditations/certification
The ideal candidate would look like:
- Extensive demonstrated pharmaceutical quality experience, including audit, batch record review, change control, complaint handling and Investigations experience
- A thorough knowledge of pharmaceutical manufacturing, packaging, testing, and distribution processes and associated global regulatory GMP/GDP requirements
- Experience of hosting / supporting regulatory inspections, client audits and self-inspections
- Solid understanding of the requirements of an effective Pharmaceuticals Quality System
- Technical knowledge to support quality and validation decision making
- Five plus years of relevant Quality Assurance experience
- Preferably: WO, Pharmacy (industrial pharmacist) and/or Qualified person conform article 29 directory 81/851/EEG
The organisation can offer:
- Salary between €70,000 and €90,000 depending on experience
- 31 holidays
- Flexibility to work a day from home
- Good secondary benefits
If you are interested in this job, or in similar ones, please feel free to contact me directly.
Sr Consultant Biotech/Pharma