Head of QMS

Bedrijfsnaam: -
Plaatsingsdatum: 10/09/2018
Standplaats: -

Functieomschrijving

SIRE® is the market leader in Life Sciences recruitment. We believe the recruitment market needs to gear up in technology and continuous innovation. We like technology, in a Life Sciences market driven on science, we couldn’t stay behind; we drive Recruitment Science. Investing a majority of our turnover in technology enables us to use unique Resource Technologies. By using highly advanced algorithms, we enable our team of Resource & Data Strategists© to maintain the most advanced, detailed and complete Life Sciences network in Europe. This big data enables us to work Reverse Recruitment©: we first analyze the market in-depth before we go out to the market. Because we analyze the whole market, we can compare facts and data. This enables us to do Facts & Big Data Recruitment©, making sure we, or better yet, you find the right career!Our client is a professional Pharmaceutical organisation, based in Noord-Holland Netherlands.The CompanyOur client is a Pharmaceutical company with a large manufacturing site in Haarlem.

Role DescriptionMaintain a team that has the technical expertise, personal skills and interpersonal skills needed to perform their duties in line with Site expectations.
Instruct employees and delegate duties as well as powers, in consultation with the persons involved
Ensure an effective internal communications structure with relevant departments
Supervise the performance of the work (both in terms of volume and quality) as well as the lead time
Measure and Monitor Execution: Consistently measure and monitor site quality key performance indicators.
Manage Department Processes: Including and not limited to timely management of investigations, CAPAs, coordination of Regulatory commitment, GRAs, Audits, standard implementation to ensure sustainable compliance.
Manage team through talent identification, active performance management, succession planning, employee development, mentoring and modeling behavior according to values.
Maintain a team that understands and maintains the rigorous standards required while retaining the flexibility to adapt to continuous evolution and change.

ResponsibilitiesEnsure robust quality systems that include monitoring and control of the manufacturing process and facilities
This includes the quality systems, manufacturing, packaging, testing, facilities and warehousing methodologies and technologies related to Teva Operations including GXP IT systems.

Change Control
Ensure that proposed changes to suppliers, processes, equipment, systems, procedures, and basic documents are assessed according to current CGXP guidelines en Global requirements.

Validation
Ensure that validation protocols are developed according to cGXP standard , processes, equipment, systems, procedures, and basic documents are assessed according to current CGXP guidelines en Global requirements.
Manage validation status of Site’s utilities, equipment and processes
Ensure that validation of systems, equipment and processes are timely performed and reported, inform management of any discrepancy.
Assure that validation of systems, equipment and processes are in accordance with current USP / Ph. Eur / JP and registration files

Documentation
Ensure that SOP´s are developed according cGXP guidelines and Global requirements.
Manage the documents in a robust EDMS and ensure proper archiving for non EDMS documents.
Assure that analysis methods are in accordance with USP / Ph. Eur / JP and files.

Transfers
Ensure product transfers across sites also include the transfer of quality information (knowledge, documentation, processes, etc.).
Coordinate requested and available capacity; deciding on outsourcing
Support transfer of analytical methods to other sites as part of the Transfer TeamSupport the receiving and implementation of methods for new products from other sites as part of the Transfer Team

cGXP
Prepare and implement department policies and objectives in line with Site policies
Ensure the implementation of and compliance with national and international quality standards (cGXP) as well as Teva Global standards
Execute the review and implementation of standards and procedures at the department.
Maintain adherence to corporate policies and appropriate regulations through actions and decisions.
Ensure that all current standard operating procedures are accurate, current with regulatory guidance and aligned with cGXPs
Assure internal as well as external complaints are investigated on behalf of the Quality Assurance department or other departments

Requirements- Experienced QMS Head / Director / Consultant
- Experience with the tasks described above

Are you interested and do want to apply for this role, please fill out your application via the apply button below and contact Daniel Woudenberg.

 

Aanbod/arbeidsvoorwaarden
-

Samenvatting

Plaatsingsdatum :
10/09/2018
Referentienummer :
95355
Standplaats :
-
Adres :
-
Postcode :
9723 HK
Opleidingsniveau :
WO
Uren :
Nader te bepalen
Dienstverband :
Detachering
Werkervaring :
3 - 5 jaar
Contactgegevens :
bekijk