quality assurance manager in maidenhead

posted
job type
contract
salary
£ 95,000 per year
apply now

job details

posted
location
maidenhead, south east
job category
pharmaceutical
job type
contract
working hours
Full-Time
salary
£ 95,000 per year
reference number
QAMMAIJ
apply now

job description

Are you an experienced Quality Assurance Manager? Are you looking to take on a new challenge with a leading consumer healthcare brand? If so we are looking for individuals just like you!

We are looking for OTC finished product manufacturing SME with RA, Quality/GMP & regulatory experience.

You will be performing a gap analysis review of production documentation against the following: registered documentation, current cGMP, internal standards, and industry standards e.g. ICH.

This opportunity for a Quality Assurance Manager is on a contract basis for 4 months initially, working 37 hours per week Mon-Fri.

Responsibilities:



* Review of the existing manufacturing site documentation will include:
* Product and material specifications
* validation documentation
* stability documentation
* Periodic Quality Reviews, complaint history and any CAPA produced as a result
* change control history
* CAPAs
* Manufacturing batch documentation
* Regulatory dossier
* Request additional documentation as required
* Carry out a Preliminary Risk Assessment
* The gap analysis will be completed using the relevant documentation to detail the cGMP Compliance and Product Health Assessment
* Carry out a Risk Assessment on the findings to prioritise activity
* Based on the regulatory variation strategy develop a manufacturing/analytical plan for the remediation work to ensure compliance.
* Request a quote for the works to be completed at the relevant manufacturing site and/or contract research organization (CRO) and agree a timescale for the works to be completed.
* Review and approve protocols and reports from the manufacturing site and/or CRO that control the required remedial work, i.e. process or analytical revalidation
* If required, prepare an Expert Statement to support regulatory submission
* Support request for information requests which may arise on regulatory variation submission
* Update client Specification systems as required
* Prepare Expert Statement to support regulatory submission
* Support request for information requests which may arise on regulatory variation submission

Experience and skills:



* A relevant degree or suitable pharmaceutical industry experience
* A minimum of 8 years in a pharmaceutical manufacturing or product development environment
* Knowledge and understanding of different manufacturing processes used with the OTC environment is a distinct advantage
* Comprehensive understanding of quality compliance knowledge within EU and good understanding of GxP systems
* Technical writing and documentation review abilities
* Project management, communication and prioritisation skills
* Demonstrable experience of working with external manufacturers
* Preferred understanding of EMEA regulatory processes and requirements
* Key Internal Stakeholders; Supply Chain - Manufacturing, Regulatory Affairs, Quality Assurance and Project Management

If you feel you have the right experience and skills for this role, and would be interested in applying, please click apply, making sure to send an up to date CV, ensuring your up to date contact details are also on your CV. We will make sure to contact you as soon as we hear back from our client to discuss the job role further.

Randstad CPE values diversity and promotes equality. No terminology in this advert is intended to discriminate against any of the protected characteristics that fall under the Equality Act 2010. We encourage and welcome applications from all sections of society and are more than happy to discuss reasonable adjustments and/or additional arrangements as required to support your application.

Candidates must be eligible to live and work in the UK.

For the purposes of the Conduct Regulations 2003, when advertising permanent vacancies we are acting as an Employment Agency, and when advertising temporary/contract vacancies we are acting as an Employment Business.