Head of Commercial QA - Operations

Lawrence Harvey

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Job ID :

7889


Company Type :

Staffing Firms


Industry :

Pharmaceuticals


Education Level :

Other


Address 1 :

United Kingdom,Kent,Kent,


Key Skills :

Director Head of Quality assurance operations


Salary :

Negotiable


Date Posted :

18 Jul, 2017



Company Name :

Lawrence Harvey


Location1 :

Kent




Job Category :

Quality Assurance Jobs


Experience :

Fresher


Job Type:

Contract


Travel Amount:

negotiable





Description

Location

Kent

Team

Member of Quality Leadership Team

Reporting to

Site Head of Quality

Direct Reports

Quality Manager (Field QA), Qualified Persons, Senior QA Executives

Role Scope



Establishment and leadership of a new QA Operations Team in support of global Commercial Supply Chain. To manage the QA activities associated with increased batch volumes for leading product, in particular the activities associated with API and Medicinal Product launch inventory and subsequent 5-year commercial supply chain demand. To ensure that the manufacturing, control, storage and distribution of commercial products are undertaken in accordance with global regulatory requirements and that own facilities are inspection ready by US FDA, EMA and UK MHRA. To support 5- Year Supply Chain Plan in particular the capacity expansion and new facility build projects located in Kent.

Key Objectives:



(1)

Quality Operations & Management

* To establish, recruit and lead a team of QA professionals (including a Field QA Manager and Qualified Persons) to support the manufacture, control and release of commercial products.
* To manage the QA activities associated with the production of Commercial API and Medicinal Products at Manufacturing Facilities and to ensure that all associated activities are undertaken in accordance with the requirements of cGMP Quality Management System (QMS).
* To ensure that the facilities in support of the above are maintained in accordance with cGMP, all equipment is verified as clean and all processes are validated/ continuously verified in accordance with current guidance.
* To ensure that all supporting documentation (to include specifications, master batch records etc.) is appropriately reviewed and approved as suitable for use.
* To establish the Commercial Control Strategy for each Medicinal Product (to include CQA/ CPP/ MQA) in conjunction with the Technical Development and Manufacturing teams.
* To establish an increased presence of 'Field QA' within production operations and introduce an approach to on-going, parallel batch record review.
* To ensure that all deviations, out of specification and other quality events are investigated (including root cause analysis), remediated and trended to ensure appropriate corrective/ preventive actions are effective. This includes deviations and quality events arising from own production activities as well as those undertaken at CMOs.
* To ensure Medicinal Product is released for clinical/ commercial use in accordance with regulatory expectations, the Regulatory File (NDA/ MAA) and by a Qualified Person (QP).
* To collaborate with appropriate departments to ensure that all commercial manufacturing activities are inspection ready by US FDA, EMA and UK MHRA.



(2)

Quality Operational Excellence

* To ensure commercial manufacturing operations remain current with new global cGMP regulatory requirements. To support the provision of associated team training, as appropriate.
* To ensure that the content of the Quality Management System (QMS) in support of commercial manufacturing operations is robust, stream-lined and compliant.
* To review, in conjunction with the Site Head of Quality, the provision of quality performance metrics (KQI) for operational implementation.

(3)

Quality Compliance

* To support the assessment of customer complaints.
* To ensure the completion of the Annual Product Reviews.

(4)

Projects

* To provide Quality support and oversight for assigned projects.


Company Name:

Lawrence Harvey


Headquarters:

150 Leadenhall Street,London


Sector:

Staffing Firms


Country:

United Kingdom


Zipcode:

EC3V4TE


Website:

www.lawrenceharvey.com


Employees:

100 - 499


Industry:

Pharmaceutical Recruitment


City:

London


Phone No. :

0203 327 3072


Lawrence Harvey Life Sciences has exceptional relationships with the top talent and leading organisations in the Pharmaceutical and Medical Devices industry across the UK, USA, DACH region and the rest of Europe. Our consultants are experts within their specific areas and have a deep understanding of the full Life Sciences developmental cycle. As a client with a challenging role or a candidate with a niche specialism, you will receive a consultative service from people who truly understand the expectations and requirements of your industry. In an ever developing industry, an in-depth technical understanding and knowledge adds significant value and is imperative to ensuring our consultants are always up to speed, positioning ourselves perfectly to offer advice, analysis and support to our clients and candidates. We partner with leading pharmaceutical, medical device, generics, biotechnology, clinical research, R&D, manufacturing, regulatory affairs, CRO’s, CMO’s and medical communications organisations and have acquired an enviable and unrivalled reputation for delivering on niche, hard to fill and challenging positions. Our Specialisms within Life Sciences: Pharmaceuticals Medical Devices Regulatory Affairs Quality Assurance Quality Control Engineering Medical Affairs / Medical Information Qualified Persons Drug safety & Pharmacovigilance Biostatistics Clinical SAS Medical Writing Account Management & Business Development

For more information,visit www.lawrenceharvey.com.

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