Are you Norgine B.V.’s next compliance guardian?
Norgine is a European specialist pharmaceutical company that has been established for over 100 years. In 2015, Norgine’s total revenue was EUR 320 million and the company employs over 1,000 people. Norgine provides expertise and ‘know how’ in Europe to develop, manufacture and market products that offer real value to healthcare professionals, payers and patients. Norgine’s approach and infrastructure is integrated and focused upon ensuring that Norgine wins partnership opportunities for growth.
Are you Norgine B.V.’s next compliance guardian? Do you have an eye for detail and are you ready to contribute to be the ‘go to’ partner? For a new position in the Benelux Medical team in Amsterdam we are looking for a Compliance Officer with experience in the industry and/or quality compliance who is able to continuously improve compliance for the business and able to setup (inter)departmental communication in both Dutch as well as English language.
The Compliance Officer is responsible, under supervision of the Medical Director Benelux / RP / QMR, for coordination, implementing, maintaining and monitoring the compliance of local and medical-related quality systems in his/her affiliate organization (Benelux) in line with relevant regulatory codes and conditions.
The Compliance Officer supports the QMR and other Quality staff in the maintenance of compliance related to the activities of the Benelux Medical Department, and their implementation, throughout the local affiliate departments. The Compliance Officer will maintain awareness of good practice in relation to Quality Assurance and ensure awareness of all relevant legislation, policies and procedures as related to the operation and integrity of his/her Affiliate organization.
Support with regard to Quality / Quality Market Responsible activities:
- Ensures that activities are performed in accordance with GxPs and Norgine policies: this includes introductory and continuous GxP training of the local Affiliate staff
- Responsible for Training Curriculum in the Netherlands
- Maintains and improves local quality management system: this includes writing/review of quality documents, development/management of quality indicators, preparation of quality reviews, maintenance and release of training curriculum matrix, maintenance of training evidence for specified staff (mainly sales reps)
- Define global and local assessment in liaison with local function leads
- Administers (ensures document controlling and authoring) the eGSOP database. This includes training of and assistance to users
- Assists the line manager in hosting audits and inspections: this includes preparation and follow-up
- Contributes to the design of annual audit plan; executes internal audits
- Oversees third parties contracts and activities
- Interfaces with global QA functions and back-fills for the line manager in QMR role
- Supports/leads specific projects as required
- Initiates regular local quality reviews for entrees in specific databases
Support with regards to Code of Practice
- Back-fills for duties and assisting in duties for the review and approval of material as required by applicable Codes of Practise, Norgine Standards, and internal processes
- Keeping abreast of developments in Code of Practice (CGR) and Medical Devices code
- Maintains and improves activities to ensure compliance with the applicable codes
- Responsible for the implementation of processes as required to ensure compliance with applicable Codes of Practice, Norgine Standards, and internal processes in the Dutch affiliate for which there is responsibility in conjunction with the Commercial Lead
- Responsible for issuing and filing of contracts subject to Code of Practice activities
- Playing a key role in the Zinc approval process as initiator
- Responsible for completion of the Transfers of Value in local database
Support with regard to Good Distribution Practice and RP related activities
- May have the ability to act as RP on the Norgine BV wholesalers license (WDA)
- Contributes to the release of all products within the Dutch market
- Contributes in handling complaints, quality defects and recalls
- Supports in self-inspection activities for the distribution chain
- Monitors storage and distribution of all products in accordance to GDP/GMP
- Write and update SOP’s (including those to be in compliance with GDP and/or GMP)
- Ability to work and lead successfully in a matrix organisation
- Works cooperatively within a team
- External relationships, plus external representation with agencies/authorities and other Industry professionals
Skills & knowledge
- Degree in a relevant life science subject (e.g. pharmacist)
- Preferably a few years' relevant experience within a pharmaceutical company
- 1-2 years’ experience in quality management acquired in the pharmaceutical industry either in a manufacturing, a development or a commercial organization
- Ability to communicate clearly in English and Dutch
- A good knowledge of quality management systems
- Awareness, understanding and an ability to pragmatically interpret GxP and Code of Practice requirements relevant to his/her responsibilities
- Demonstrates a good ability to analyse data and develop processes
- Focuses on customer needs, follows up on commitments and requests
- Good interpersonal skills
- Excellent verbal and written communication skills
- Delivers goals in a changing environment
- Computer skills (Work, Excel, PowerPoint, and Database) are essential
- Self-reliance, professionalism, high ethical standards and attention to detail are key qualities
- Takes a creative and innovative approach to work
- Be self-motivated with a proactive nature
Monday 10 April 2017.
Acquisition by third parties is not appreciated.
Trefwoorden: quality controller, quality specialist, kwaliteitsmedewerker, medewerker kwaliteit, kwaliteitscontroleur, kwaliteitscontrole, controle kwaliteit, safety officer, controleur kwaliteit, controller medisch, audit, auditor, farma, farmaceutisch medewerker