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Job Details

Senior Quality Assurance Specialist

Company: CROMSOURCE
Location: United Kingdom
Reference: HQ00000901
Closing Date: 19 Sep 17
Type: Contract
Salary (£): On Application
Benefits: Excellent and Comprehensive Benefits – see below

Job Summary:

TalentSource Life Sciences is currently searching for an experienced Senior Quality Specialist to work with one of our partner pharmaceutical companies in the South of England.     This is a freelance position with TalentSource for 12 months with the possibility of being extended, on a full time basis. This will be an office based position along the M4 Corridor initially, with potentially some flexibility to work from home after the first 3 months.

Requirements:

TalentSource Life Sciences is currently searching for an experienced Senior Quality Specialist to work with one of our partner pharmaceutical companies in the South of England.

This is a freelance position with TalentSource for 12 months with the possibility of being extended, on a full time basis. This will be an office based position along the M4 Corridor initially, with potentially some flexibility to work from home after the first 3 months. The successful candidate will be working on studies dedicated to one client.

The Senior Quality Specialist will deliver global procedural document packages to GCP and GVP requirements. The Quality Specialist will be responsible for writing global procedures based on interpretation of regulations, working with global process owners and other functions to update existing documents and for the quality control output of documents.

TalentSource is the division of CROMSOURCE dedicated to flexible staffing solutions. Through us, you will have the opportunity to be integrated into a sponsor-led team, whilst having the continuous support from your TalentSource Line Manager who will work closely with you to support your professional development and growth.

Job purpose:

Implement the controlled document strategy for Quality Services department and the supported business partners for all relevant regulatory compliance standards and processes related to clinical development and safety/pharmacovigilance.

Develop Standards, Policies and SOPs, from identification of needs, to execution of development and deployment of outputs and materials.

Responsibilities:

·  Supports establishment of GxP Standards; Policies & SOP throughout all of the client's development related organizational enterprises to ensure a consistent documents landscape for standards and processes related to clinical development and safety/pharmacovigilance which meet internal and external standards versus regulatory and compliance related regulations and interpretations with Senior Quality Specialist support and coaching

· Builds and maintains strong relationships with key business stakeholders and ensures that department is providing an efficient, effective and compliant process landscape to the functions.

· In close collaboration with supported functional areas and with coaching from senior team members and key business stakeholders, identifies needs for process standardization, regulatory compliance direction and areas for improvement.

· Ensures that business partner expectations for SOP strategy, materials and deployment are met.

· Ensures in collaboration with business partners that Policies and SOPs in the controlled document landscape are up-to-date and regulatory compliant versus current Clinical and safety/pharmacovigilance international regulations.

· Collaborates with a network of subject matter experts (SMEs) within the functional areas supporting policy and SOP development.

· Contributes to the department's Standards & Processes Team to set strategies and achieve the long-term goals & objectives for quality services.

· Is knowledgeable of all services and activities provided by department, Standards &Processes in order to provide business stakeholders with a comprehensive overview and effectively communicates how their training needs can be met.

Qualifications Required

Education/Qualifications:

· Bachelor degree in a science-related subject or other related field.

· Strong previous experience in the pharmaceutical industry, preferably development and working in a GxP regulated area; understanding of global expectations of Health Authorities in the area of Pharma Development.

· Experience in preparation, development and administration of GxP standards and processes.

· Organizational awareness (e.g. interrelationship of departments, business priorities), including significant experience working cross-functionally and in global teams.

· Applicants must have a demonstrated knowledge of GCP, Pharmacovigilance/drug safety and regulatory requirements, as well as analytical, organizational and planning skills.

Experience, Skills, Knowledge

· Solid knowledge of GCP, PV and regulatory requirements.

· Customer focused approach, and highly effective teamwork and collaboration skills.

· Ability to build and maintain good relationships with key business partners.

· Ability for problem identification / resolution in a complex environment or potential conflict.

· Ability to analyze and simplify complex systems

· Effective communication and influencing skills and leading without authority.

· Ability to work effectively in an international multicultural matrix organization.

· Fluency in written and spoken English.

If you have the experience and are interested in discussing the role for this position, please contact Laura Guascone, Account Manager, Laura.Guascone@CROMSOURCE.com.

Why TalentSource Life Sciences/Cromsource?

Cromsource is a family-owned, high quality ISO-certified international provider of outsourced services to the pharmaceutical, biotechnology and medical device industries. Since 1994, we have been supporting our clients with outstanding clinical research and staffing solutions services. TalentSource Life Sciences is a fully dedicated flexible resourcing unit within CROMSOURCE and the successful growth has been achieved by putting high quality and client focus at the heart of everything we do.

Our employees are the most valuable company asset and we value resources and ensure they work in a friendly, family environment and develop their skills and talents. Human Resources is the fulcrum around which all activities are built and close management and training is the core instrument to develop and maintain highly-qualified personnel. The continuous training keeps the resources qualified in terms of competence and expertise and gives to all personnel clear tools to manage both internal and client processes with the same methodology.

Our approach is to equally value our clients and our own people. We know that we are not simply providing 'staff' or 'resources'. We are providing expert people. Highly talented, well trained, motivated people who make a positive difference to the work of our clients every day. Together we help our clients succeed in their work developing medicines and medical devices for patients around the world. Our large management team consists of a people with an extended experience within pharma and a high level of market knowledge. We our open, friendly and approachable and aim to support you through the recruitment process every step of the way.

As this position is client-facing, the successful candidates must be confident and be able to drive the role and themselves and to work autonomously in close liaison with a line manager at TalentSource, who will provide you with mentoring and guidance.

To ensure the success of our clients, our team of international professionals is focused on continuous improvement. We invest in our employees by providing the coaching and training necessary to deliver high quality services for our clients.

Every day we strive to create an environment in which all employees can contribute to their full potential and at the same time allow the company to develop and grow with them. With CROMSOURCE you will be able to participate in exciting projects and achieve your professional goals.

Keywords: Quality Assurance, Quality Specialist, Quality Consultant, Consultant, Quality, GCP, GxP, GVP, CRO, Outsourced, Freelance, Contract, QA, Contract Research Organisation, Pharmaco

Quality Assurance Specialist, Freelance

Apply for this job: Senior Quality Assurance Specialist

Contact Information:

Address:  UK Office
CROMSOURCE Suite 3 Lomond Court Castle Business Park Stirling United Kingdom
FK9 4TU
Scotland
Tel:  +44 (0) 1786 468990
Website:  Visit Our Web Site

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