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Job Details

Qualified Person & Manager, Quality Management Systems

Company: Clinical Professionals Ltd
Location: South East
Reference: J30504
Closing Date: 13 Oct 17
Type: Full Time
Salary (£): Negotiable
Benefits: Competitive + Benefits

Job Summary:

Qualified Person & Manager, Quality Management Systems. An exciting opportunity to join a Global Generics company who are recruiting a fully certified Qualified Person as per (2001/83/EC) to be named on their licence and have responsibility of releasing product batches across the UK, Europe and Emerging Markets.

Requirements:

Qualified Person & Manager, Quality Management Systems
Location: Home Counties
Salary: Negotiable/dependent on experience
Duration: Permanent
An exciting opportunity to join a Global Generics company who are recruiting a fully certified Qualified Person as per (2001/83/EC) to be named on their licence and have responsibility of releasing product batches across the UK, Europe and Emerging Markets. You will also manage a team of 4 Quality Assurance Officers within the QMS team, head up the design, ongoing maintenance and development of the QMS and work closely with the Quality Director to recommend process improvements across the entire QA department.
Responsibilities (to include, but not limited to):
* Responsible for the design, development and implementation of a single European (regional) Quality Management System compliant with EU cGMP.
* Release batches according to EU cGMP, when required in line with QP responsibilities.
* Maintain information with respect to non-EU suppliers, monitoring them continuously for documentation of certification and compliance.
* Liaise with the CQA globally to ensure that the European QMS is integrate-able with corporate QMS and is compliant with corporate policies and standards.
* Lead the Quality Systems team.
* To prepare and review management reports and periodic quality reviews.
* Devise, review, implement and review systems within the group, including communication, GMP training and information management, to achieve continuous process improvements.
* Design the system such that both management and QPs have continuous information regarding the performance of both products and quality processes.
* Prepare, update, review and approve technical agreements to regulate distribution of pharmaceutical responsibilities across the organisation.
Experience required:
* Life Science degree (ideally in Biology, Chemistry or Pharmacy) at Bachelor's level preferably supported by PhD, MSc or MBA.
* Qualified Person as per 2001/83/EC.
* Minimum of 3 years' experience in batch release, CAPA investigations and deviations handling for a variety of dosage forms.
* Auditing experience - EU cGMDP/ICH Q7A/ISO9001/PS9001/ISO13485.
* Experience in the design and management of a quality system.
* Line management experience (Preferred).
* Experienced in hosting regulatory authority inspections.
* Thorough knowledge and extensive experience of EU cGMDP, Regulatory Affairs, QMS, handling Change Controls, CAPAs, Deviations, Complaints, Complaint Investigations and (both manual and software-based) documentation systems.

If however, you do not feel that this is the right role for you, please forward these details on as we have a generous referral scheme in place.
Please note due to the high level of applications if you are not contacted within a week, you have not been successful on this occasion.

GXP, GMP, GDP, Qualified Person, 2001/83/EC, Audit, Auditor, R&D, Generics, QA, Quality Assurance, Global, SOP, Audits, CAPA, Quality Management System, QMS, Home Counties,

Apply for this job: Qualified Person & Manager, Quality Management Systems

Contact Information:

Address:  Clinical Professionals UK
3rd Floor
33 Blagrave Street
Reading
Berkshire
RG1 1PW
England
Tel:  0044 118 959 4990
Fax:  0044 118 956 0607
Website:  Visit Our Web Site

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