PQE Group

Technical Writer- Pharma

Posted 24 days ago

Job summary

  • Job post source

    This job is directly from PQE Group

  • Job overview

    The Technical Writer- Pharma role at PQE Group involves creating and maintaining high-quality technical and procedural documentation to support pharmaceutical and medical device industry projects, impacting compliance and process clarity.

  • Responsibilities and impact

    The candidate will collaborate with IT and business teams to gather information, develop and maintain SOPs, validation protocols, user manuals, and training materials, ensure regulatory compliance, assist in documentation planning for ERP implementations, and manage document versions and reviews.

  • Experience and skills

    The position requires proven experience in structured documentation for ERP implementations in life sciences or pharmaceuticals, familiarity with Kneat software, knowledge of regulated documentation practices (GMP, GCP, GAMP 5), excellent communication skills, and a relevant bachelor's degree; certifications are a plus.

  • Career development

    PQE Group offers opportunities to work on international projects, improve skills, and collaborate in a multicultural environment, supporting professional growth and learning.

  • Work environment and culture

    PQE Group values collaboration and innovation within a challenging, multicultural workplace that encourages interaction across global teams.

  • Company information

    PQE Group is a world leader in pharmaceutical and medical device industries since 1998, with 40 subsidiaries and over 2000 employees worldwide.

  • Application process

    Applicants will be contacted by the Recruiting department for an initial HR interview if matched, followed by a technical interview with the Hiring Manager, with further steps communicated based on interview outcomes.

Company overview

PQE Group is a global consulting firm specializing in quality assurance, engineering, and regulatory affairs for the life sciences industry. Founded in 1998 in Italy, the company has grown to offer a wide range of services including compliance, data integrity, and validation to pharmaceutical, biotechnology, and medical device companies. PQE Group generates revenue by providing expert consulting services and tailored solutions to ensure clients meet industry standards and regulatory requirements. With a presence in over 20 countries, the company is known for its commitment to innovation and excellence in the life sciences sector.

How to land this job

  • Tailor your resume to highlight your experience in creating structured technical documentation for ERP implementations like SAP or Oracle, especially within the pharmaceutical or life sciences sectors, to align with PQE Group's core needs.

  • Emphasize your familiarity with regulatory documentation standards such as GxP, GMP, GCP, and 21 CFR Part 11, and any experience using electronic documentation tools like Kneat, as these are critical to PQE's compliance requirements.

  • Apply through multiple platforms including PQE Group's official corporate website and LinkedIn to maximize your chances of being noticed by recruiters and hiring managers.

  • Connect with current PQE Group employees in the pharmaceutical or technical writing divisions on LinkedIn; initiate conversations by complimenting recent PQE projects, asking about their experience working on ERP documentation, or inquiring about company culture to build rapport.

  • Optimize your resume for ATS by incorporating keywords from the job description such as 'technical documentation,' 'ERP implementation,' 'GxP compliance,' 'Kneat software,' and 'validation protocols' to ensure your resume passes automated screenings.

  • Leverage Jennie Johnson's Power Apply feature to automate the tailoring of your resume, identify all relevant application channels, and discover LinkedIn contacts for networking, allowing you to focus your energy on preparing for interviews and refining your expertise.

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