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Job Details

SOP Systems Specialist

Company: Roche
Location:
Reference: 3426549128
Closing Date: 24 Mar 18
Type: Full Time
Salary (£): On Application
Benefits:

Job Summary:

As the SOP Systems Specialist you will provide system support to Business in generation, deployment and rollout of controlled documents (CD) for all supported business functions (gRED, pRED, PD, GPS and affiliates). You will also maintain the system and database for management of Controlled Documents within PDQ and the supported business functions for all relevant regulatory compliance processes. ...

Requirements:

As the SOP Systems Specialist you will provide system support to Business in generation, deployment and rollout of controlled documents (CD) for all supported business functions (gRED, pRED, PD, GPS and affiliates). You will also maintain the system and database for management of Controlled Documents within PDQ and the supported business functions for all relevant regulatory compliance processes. You will routinely report and analyze metrics related for controlled documents and systems within PDQ and the supported business functions, and drive follow-up where required
Your further Tasks and Responsibilities:

  • Supports the deployment of the PDQ QS Service model for all supported business functions (gRED, pRED, PD, GPS and affiliates)
  • Ensure timely development and rollout of controlled documents according to the service model and ensure they are compiled and issued on time and periodic status updates are prepared and reported
  • Ensures CD updates and revisions are adequately communicated to business stakeholders
  • Collaborates proactively with the training team within PDQ for the proper training implementation strategy
  • Uses innovative IT tools and User Interface solutions required to support the maintenance and usability of the controlled documents in a compliant and efficient manner
  • Ensures first Level support issues (e.g., user requests, change control) are resolved in a timely manner
  • Builds and maintains strong relationships with key business stakeholders and ensures that PDQS is providing efficient, effective, value added training support to the functions
  • Identifies and follows up on issues and delays through robust SOP compliance metrics and reports
  • Ensures that business partner expectations for SOP rollout and deployment are met
  • Contributes to the PDQ QS SOP Team to set strategies and achieve the long-term goals & objectives for PDQ QS and PDQ as a whole
  • Is knowledgeable of all services and activities provided by PDQ QS in order to provide business stakeholders with a comprehensive overview and effectively communicates how their training needs can be met

Who you are

You’re someone who wants to influence your own development. You’re looking for a company where you have the opportunity to pursue your interests across functions and geographies. Where a job title is not considered the final definition of who you are, but the starting point.

You have a Bachelor degree in Science-related subject or other related field and demonstrable experiencein the pharmaceutical industry, preferably development and working in a GxP regulated area; broad understanding of global expectations of Health Authorities in the area of Pharma Development.
Your further Skills and Qualifications:

  • Demonstrated knowledge of GCP, Pharmacovigilance/drug safety and regulatory requirements, as well as analytical, organizational and planning skills (all mandatory)
  • Experience in implementing processes & procedures in a regulated area
  • Experience including oversight and administration of validated electronic systems such as ConDor or other document management systems
  • Considerable organizational awareness (e.g. interrelationship of departments, business priorities), including significant experience working cross-functionally and in global teams
  • Substantial knowledge of all services and activities provided by PDQ, Change Management expertise
The closing date is: 23rd February 2018

Who we are

Basel is the headquarters of the Roche Group and one of its most important centres of pharmaceutical research. Over 8,500 people from approximately 90 countries work in Basel, which is one of Roche`s largest sites. Read more.

Roche is an equal opportunity employer and strictly prohibits unlawful discrimination based upon an individual’s race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, mental/physical disability, medical condition, marital status, veteran status, or any other characteristic protected by law.

Apply for this job: SOP Systems Specialist

Contact Information:

Address:  UK Head Office
P.O. Box 8, Welwyn Garden City, Hertfordshire, United Kingdom
AL7 3AY
England
Tel:  +44 1707 36 6000
Fax:  +44 1707 33 8297
Website:  Visit Our Web Site

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