Qualified Person QP

Recruiter
Seven Life Sciences
Location
Doncaster
Salary
£60k - 75k per year
Posted
02 Dec 2017
Closes
05 Jan 2018
Sector
Healthcare
Contract Type
Permanent
Hours
Full Time
To participate in maintaining the quality systems associated with the company's manufacturing licenses (MIA and MIA (IMP)) and to undertake routine product and IMP certification as a Qualified Person in accordance with article 51 of 2001/83/EC and Annex 16 of Good Manufacturing Practice Part I (Eudralex volume 4).

This role reports to the lead QP and requires close working relationships with the QA team and other QPs.

The role requires liaison with management on the site and at other sites, including but not limited to: the site Operations Manager; the Group Regulatory Services Manager; and the site Clinical Trials Managers. Furthermore, maintenance of professional relationships with clients and vendors will be required.

Responsibilities

Quality System

* Assist in maintaining GMP, GDP and GCP standards across all site operations
* Assist in the development and approval of new Standard Operating Procedures (SOPs)
* Assist in the generation and approval of production documentation
* Assist in driving the change control process and assist in managing change as required including the provision of training against the needs identified
* On a project basis, to lead or assist in the redesign of systems or premises
* Take responsibility for specific areas of the quality system as required
* Assist in the introduction of new client work to site ensuring all processes have been adequately followed. Assist in ongoing maintenance of documentation
* To assist in the follow-up and completion of complaints and deviations, taking into account root causes and provision of any training needs identified
* Investigation and follow-up into product recalls, including reporting to the DMRC where required
* Alerting site management to issues relating to the quality system
* Participation in the internal audit schedule and audits of vendors where required
* Participate in audits of the site and operations and assist in the completion of actions arising from these audits
* Assist in the collation of performance data for quality review and attend the meetings where this data is discussed
* Deputise for the Lead QP as required

Product certification

* To perform the review and certification as suitable for release for sale batches of product processed at the site
* To perform the review and certification as suitable for use batches of clinical trial materials received onto site and those requiring further processing
* To perform the review and certification as suitable for release for sale batches of product imported on behalf of third parties
* To record any deviations identified during the review and certification process and ensure that adequate investigation is performed.

Continuing Professional Development

* Maintain familiarity with current industry practice and any changes to national or European legislation
* Maintain a record of training or study undertaken in line with professional body requirements

Other

* Any other duties that may be necessary form time to time, as agreed with the Lead QP

Person Profile

* Registered EU Qualified Person with relevant experience within the pharmaceutical industry
* Detailed knowledge of current GMP requirements and working knowledge of current GDP requirements
* Good understanding of the pharmaceutical manufacturing sector in the UK, EU and third countries
* Experience of working with electronic QMS solutions, such as Q-Pulse
* Demonstrable strong leadership capabilities
* Capable and confident communicator (written and verbal) at all levels with first class presentation skills
* Commercially astute and customer focused
* Demonstrable analytical and problem solving abilities
* Excellent project management skills and demonstrate completer-finisher abilities
* Have a hands-on approach with an enthusiastic can-do attitude
* Have the ability to self-motivate and motivate others to deliver
* Demonstrable coaching and mentoring skills