Technical Writer (GMP)

14 October 2021
SalaryUp to €0.00 per hour + Negotiable
LocationHoofddorp
Temporary
DisciplineLife Science Careers, Quality Assurance/Safety
ReferenceBBBH487485_1634193923

Company
Our client is a Biopharmaceutical company in the Amsterdam area. Their focus is on immunotherapy, especially in CAR-T cell therapy. Do you want to be part of their mission of curing cancer?

Position
The technical writer is responsible to prepare technical documents for global use within Operational Controls including: Qualification & Validation, Facilities Design & Maintenance, Vendor & Materials Management, Production & Disposition, and Product Distribution, and Governance Controls: Management Responsibilities, Training & Qualification, Event Management, Document & Change Management, Quality Risk Management.

Responsibilities
* Includes, but not limited to, document authoring, coordination of review and comments resolution, approval, issuance, implementation, periodic review, and retirement.
* Perform compliance assessment of procedural documents against evolving global health authority regulations and health authority inspection observations.
* Support Global Product Development & Supply organization for the Client's electronic document management system.
* Synthesize feedback from SMEs/procedural document teams to identify and resolve issues in order to accurately document current and future processes.
* Proactively use judgment to manage risk and uncertainty, and to anticipate the need for and implement contingency plans.
* Effectively participate on projects, escalate issues as necessary and identify/meet key milestones.
* Work with limited guidance to manage the development of global procedural documents and, seek input as needed.
* Exercise sound judgment, using a risk-based approach, to ensure compliance with procedural document regulations, practices, and policies.
* Ability to identify, manage, and/or escalate issues and risks to timelines.
* Collects and shares best practices through direct communications and communities of practice.

Required Skills
* Minimum of a BSc degree.
* 5+ years' experience in the Biopharma/Pharmaceutical industry.
* Excellent technical writing skills.
* Expert in MS Office and Collaboration applications.
* Experience with electronic documentation management systems (preferable, not required).
* Critical thinking skills in analyzing and exercising judgment on complex issues, guided by a thorough understanding of quality philosophy.
* Strong verbal and written communication skills in English and preferably Dutch.
* Project management concepts, strategies and skills.
* Proven ability to understand complex processes/problems and propose alternate solutions to implement global procedures.
* In depth knowledge of cGxP requirements (includes GMP, GDP, GCP, GLP, GVP) and global health authority regulations with ability to interpret, apply and implement.
* Demonstrated ability to successfully manage competing deadlines and balance priorities while meeting or exceeding expectations.
* Strong negotiating and influencing skills in a matrixed organization.
* Ability to drive consensus, performance and to lead strategically.
* High level of competency in procedural document writing including the appropriate use of grammar, syntax and organization of ideas.
* Ability to participate on teams, foster partnerships across multidisciplinary teams and to resolve complex issues and differences in a creative, constructive and diplomatic manner.
* Demonstrated ability to work independently.

Offer
* Temporary project for a minimum of 3 months with possible extension.
* Start asap.
* An attractive compensation package.
* Office-based, remotely or a combination.

Please contact Hajar Amagir via +31 6 26326600 for more information or apply directly!

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