job details for:
Pharmaceutical - Quality & Regulatory Compliance Advisor Jobs - Berkshire

Pharmaceutical - Quality & Regulatory Compliance Advisor Jobs - Berkshire (Job Ref: WR/JOBS/24446-10766)

Job Description :

Flame Pharma Pharmaceutical - Quality & Regulatory Compliance Advisor Job - Berkshire:

Job Summary

Our client’s Quality & Regulatory Compliance (QRC) function provides corporate quality oversight to support the company’s operations. As a result QRC Specialists are actively involved in a range of activities to ensure that processes and deliverables meet the expectations of customers, regulatory bodies and management. They will participate in and conduct customer and supplier audits and will be expected to provide regulatory consulting services and relevant training to internal staff across the International region which encompasses Europe, Japan and Australia.

Job Title

Quality & Regulatory Compliance Specialist

Background

Due to expansion, our client is looking to recruit a Quality & Regulatory Compliance Specialist to be based in Maidenhead.

Key Responsibilities

· To provide regulatory guidance to internal staff and external customers with specific focus on 21 CFR part 11, GCP, data protection / privacy issues and drug/device safety reporting issues.

· To manage the planning and conduct of customer/internal audits together with resolution of any findings identified.

· To support strategic goals by providing leadership with regard to quality improvement initiatives.

· Identifying improvement opportunities within the Quality System and managing updates to relevant documents (e.g. Standard Operating Procedures) and training materials.

· Assist in supplier management programs through ongoing monitoring of the quality of supplier deliverables.

· Support for internal quality improvement initiatives.

· To assist sales and marketing functions with regard to Quality & Compliance related issues and customer proposals.

· To assist delivery organisations through review and assessment of project deliverables.

· To prepare and deliver staff training courses on regulatory related subjects.

· Monitor developments in the external regulatory environment and alert management to any possible business impact.

· Investigate and support the remediation of customer complaints.

· As required to represent our client on external working parties/committees.

Qualifications and Experience

· Ideally, a life science or computing graduate with quality assurance experience gained within a pharmaceutical / biotechnology, medical device company or CRO.

· Alternatively, a strong software development background with sector experience of validation.

· Domain experience of the application of computer validation methodologies to clinical systems.

· Experience of conducting internal and supplier audits (especially of software/hardware vendors).

· Familiarity with key regulations and guidelines regarding clinical research and the use of computerised systems.

· An understanding of principles and practices of drug or device safety.

· Previous exposure to data protection and privacy policies or strategies.

· Demonstrable experience in process improvement.

· Attention to detail with an organised and thorough approach to work.

· Strong and confident communicator with the ability to operate at all levels using a variety of formats (written, verbal and presentations).

· Computer literate.

· Flexible and professional attitude.

· Leadership and influencing skills.

Benefits

With this position comes an attractive benefits package that you associate with a world leader, circa £35000 including pension, healthcare.

Key Words

Quality & Regulatory Compliance, Clinical Research, Clinical Trials, Medical, Clinical, CRO, Study Management, Clinical Management, Pharmaceutical, Career, Research

This role is to be based in Maidenhead. For further information about this role, please contact Flame Pharma.