Banner Default Image

QA Specialist

Location: Macclesfield Salary: Negotiable
Sector: Pharmaceuticals Type: Contract
Contact: Ruan Marx Job Published: 22 days ago

Process Owner Qualification/Validation and Risk (Quality Assurance Associate)


Take the responsibility to ensure our pipeline becomes a reality

Take the lead in ensuring the hard work from the rest of the business is realised, as we reliably get every medicine out to patients without challenge. We never give up in diligently ensuring our patients receive quality and safe medicines, responding to a large variety of, often complex, demands.

We are now looking to recruit an experienced Quality Professional, with a high level of technical knowledge in Risk, Qualification and Validation, underpinned by process knowledge across a range of manufacturing areas with particular focus on key Pharmaceutical Quality Systems. The role takes ownership and governance of a critical quality process in a new customised digital platform.

What you'll do:

As Business Process Owner (BPO) you will be the primary point of contact for QA matters related to the support of two Business Processes; Qualification/Validation and Quality Risk. You will take accountability for how critical quality processes are executed across the site, ultimately being responsible for procedural instruction and training required to ensure the site retains the required process capability.

As leader of the governance team you will work in the Process Network framework to communicate both to the governance team and from the team to the site leadership /regional organisation. You will chair networks responsible for ensuring continued process compliance whilst defining and delivering process improvement projects.

You will be accountable for collaborating in data analysis and report creation on quality metrics and key performance indicators related to area of responsibility. In addition, you will perform Process Maturity Assessments, striving to constantly improve the Pharmaceutical Quality System.

You will support cross-functional colleagues in their day to day roles with associated Pharmaceutical Quality Systems, whilst acting as a subject matter expertise for the new customised digital validation platform; GVLMS in VEEVA.

As a BPO and Local Process Champion, collaborate with regional governance teams to support routine process execution and business change. This may be to work with the governance team to support direction, definition and solution design in line with AZ Global Policies, with a view to delivering continuous improvement opportunities

Experienced in managing risk you will use evaluative judgement in complicated or novel situations, owning Business Continuity Plan for the process.

You will have a direct involvement with regulatory inspections where you act as BPO for the site PQS.

Proactive by nature, you will look for opportunities to identify change and make efficiency savings, influence decisions and deliver the results whist ensuring an appropriate level of compliance.

Knowledgeable of evolving regulatory compliance practices and recommends implementation strategies to QALT, you will share best practice as appropriate.

There are so many fantastic employee benefits that we offer! A competitive salary, private healthcare, a fantastic holiday allowance, phenomenal training and development opportunities, and much more.

Services advertised by Gold Group are those of an Agency and/or an Employment Business.
We will contact you within the next 14 days if you are selected for interview. For a copy of our privacy policy please visit our website.