Job Description
Summary of the Document Controller role
As the Document Controller you will be responsible for maintaining and updating the cGMP document system that supports the efficient control and management of the organisations documentation.
Based at our site in Deeside you will work a shift pattern of Monday-Friday 35 hours per week.
Reporting directly to the QA Manager your role will be an integral part of the Quality team where you will ensure GMP compliance for the documentation system within the QC, maintenance and manufacturing facilities, adhering to health and safety within the facility and aim to maintain and improve the system via corrective action and continuous improvement.
This is an exciting growth opportunity within a new and growing environment working as part of a small team with a future of growth and expansion.
Your responsibilities
- Maintaining and updating cGMP compliant documentation and data control system.
- Managing all aspects of paper and electronic document control and archiving system.
- Working closely with all functions and departments to ensure efficient running of the system according to cGMP and other regulatory requirements.
- Managing the process of distribution and communication of documents with both internal and external bodies.
- Managing and organising the availability of documents during customer and regulatory inspections.
- Managing documentation and continuous improvement.
- Ensuring document tracker and metrics (e.g. SOPs, CAPA, Deviation, Change Control) are up to date and document owners are informed of requirements.
- Embodying our company values, which are: be reliable, be caring, be transparent and be willing.
Requirements for the role
- Previous experience in a document control role is essential, ideally within a GMP environment.
- Ideally have a good understanding of the application of cGMP regulatory requirements and the application of this within a manufacturing environment.
- Experience of MS Office including Word, Excel and Powerpoint.
- Must be able to work accurately, with good attention to detail and organisational skills.
- Must be able to prioritise and manage varying workloads.
- Good communication skills with the ability to form strong working relationships with stakeholders at all levels across the organisation.
How you will be rewarded
We offer a competitive compensation and benefits package including bonus, pension scheme, private healthcare, Perkbox, 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
If you have the necessary skills and experience to join our team, please apply online. For any queries or should you require any reasonable adjustments to support your application please contact [email protected]
Sterling Pharma Solutions is an equal opportunities employer and positively encourages applications from suitably qualified and eligible candidates regardless of sex, race, disability, age, sexual orientation, marriage or civil partnership, pregnancy or maternity, religion or belief.
Job Types: Full-time, Permanent
Salary: £25,000.00-£40,000.00 per year
Benefits:
- Company events
- Company pension
- Cycle to work scheme
- Employee discount
- Free flu jabs
- Free parking
- Life insurance
- On-site parking
- Private medical insurance
- Referral programme
- Relocation assistance
- Sick pay
- Store discount
- Transport links
- Wellness programme
- Work from home
Schedule:
- 8 hour shift
- Day shift
- Holidays
- Monday to Friday
Supplemental pay types:
Work Location: In person
Application deadline: 05/04/2023
Reference ID: VN560