Senior Quality Assurance Officer

7 months ago


Cramlington, United Kingdom Sterling Pharma Solutions Full time

**Summary of the Senior Quality Assurance Officer role**

As the Senior Quality Assurance Officer, you will be responsible for performing batch sentencing activities on products and will be ensuring all quality assurance activities have been complete - this will include reviews, approvals, and audits.

Reporting directly to the Senior OQ Manager, you will be based at our Cramlington site and work 37 hours per week, Monday to Friday. This role will be temporary for up to 12-months.

**Your responsibilities**
- Sentencing all controlled intermediates and finished goods in an agreed timeframe, in accordance with written procedures. These will be relating to production and analytical review, deviation, and change assessment.
- Responsible for approving of documents and changes relating to process, analytical and engineering procedures, ensuring they are carried out in accordance with relevant product registrations.
- Performing assessments for decision paths, non-conformances and deviations - including out of calibration.
- Reviewing all current Good Manufacturing Practice (cGMP) and ensure manufacture is not commenced prior to completion.
- Coordinating of validation activities.
- Maintaining Operational Quality systems covering change control.
- Handling complaints, audit observations and customer notifications, as well as coordinating annual reviews.
- Embodying our company values, which are: be reliable, be caring, be transparent and be willing.

**Requirements for the role**
- Degree or equivalent in a scientific discipline would be beneficial.
- Prior experience within a similar background in a Quality Assurance role is essential.
- Must have an up to date and comprehensive knowledge of cGMP requirements applicable to the pharmaceutical industry.
- An understanding of auditing principles and practices would be preferred.
- Excellent verbal and written communication skills are essential.

**How you will be rewarded**

We offer a competitive compensation and benefits package including bonus, pension scheme, private healthcare, Engagement Hub, cycle to work scheme, death in service coverage, on-site health and wellbeing support including medical consultations and physiotherapy, 24/7 employee assistance programme, employee referral scheme, sports and social club as well as opportunity for training and further career development.

**Why consider Sterling?**

Sterling Pharma Solutions is a global contract development and manufacturing organisation (CDMO) with more than 50 years’ experience in developing and manufacturing Active Pharmaceutical Ingredients (APIs). This is complemented by Antibody Drug Conjugate (ADC) research and development bioconjugation services.

We are a fast growing, dynamic business with facilities in the UK, US and Europe, where we employ more than 1300 talented and passionate people who support our customers in bringing new medicines to market, improving and saving the lives of patients.

Our culture and our way of working is what really sets us apart as a business; we aim to deliver an exceptional experience to our customers and our employees. You can expect to be part of a supportive team, all working towards a shared goal: to deliver first-class science and service to our customers every day.

**How to apply**

**Job Types**: Full-time, Temp to perm
Contract length: 12 months

**Salary**: From £30,000.00 per year

**Benefits**:

- Employee discount
- Life insurance
- Referral programme

Schedule:

- Day shift
- Monday to Friday

Application question(s):

- Do you have experience working within a Quality Assurance role within the pharmaceutical industry?
- This role is based in Cramlington, Northumberland. Are you able to reliably commute to this role daily?
- Are you eligible to work in the UK? Please provide relevant details

Work Location: In person

Reference ID: VN699



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