quality assurance manager in maidenhead

posted
job type
contract
salary
£ 250 per day
apply now

job details

posted
location
maidenhead, south east
job category
pharmaceutical
job type
contract
working hours
Full-Time
salary
£ 250 per day
reference number
QAM
apply now

job description

Are you an experienced Quality Assurance Manager? Are you looking to take on a new challenge with a Consumer Heathcare Product Manufacturer? If so we are looking for individuals just like you!

We have an opportunity for a Quality Assurance Manager to join a leading client of ours. This is a contract opportunity for 5 months initially, working 40 hours per week Mon-Fri.

Benefits;



* Free on-site parking
* On-site restaurant
* Weekly pay
* Pension contributions

Responsibilities;



* Review of the existing manufacturing site documentation will include (E.g Product and material specifications, validation documentation, stability documentation etc.)
* 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 Specification systems as required.
* Prepare Expert Statement to support regulatory submission
* Support request for information requests which may arise on regulatory variation submission
* Update Specification systems such as GSS, CONNECT, etc.

Key Internal Stakeholders;



* Supply Chain - Manufacturing
* Regulatory Affairs
* Quality Assurance
* Project Management

Experience/Qualifications Required;



* Educational - 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.

If this role is of interest to yourself, and matches your skills sets and experience then please click apply below to submit your CV. Please ensure your up to date contact details are on your CV before applying. If your application is shortlisted, we will call you and discuss the role in further detail to ensure this role is what you are looking for and meets our client's needs.

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.