Ian C Hull BA (Hons) Dip RP
2 months ago
Quality Officer (Pharmaceutical and Food) - Permanent Position based in Cheshire
About Our Business
Tata Chemicals Europe's sodium bicarbonate is extremely versatile and used in a wide range of applications and industries. It can be both an Active Pharmaceutical Ingredient (API) and an excipient, used in haemodialysis and tabletting, an important food and animal feed ingredient, and has numerous technical and industrial applications as well.
TCE is recognised as one of the world's leading sodium bicarbonate producers, and we export to over 50 countries globally. Quality is at the heart of being able to satisfy such a diverse range of customers and industries, and the company is certificated to a number of standards including cGMP, BRC, ISO9001:2015 and FEMAS, and is registered with a number of overseas health authorities.
The company has exciting plans to grow this business further, so this is a fantastic opportunity to join an already world leading company and help make it even more successful.
To ensure that the company satisfies the Quality Assurance & Compliance requirements of its customers and regulatory standards, including (GMP, BRC, ISO9001 and FEMAS) for its sodium bicarbonate business.
Responding to the Head of Quality & Business development, the main responsibilities of the Quality Officer role are to provide practical quality assurance and compliance support and guidance for the sodium bicarbonate business unit.
Take day-to-day ownership of the SB Quality Management System, including writing, reviewing, approving and issuing quality documentation - SOPs, quality plans, reports
Perform batch release of pharmaceutical and food grades using SAP
Work closely with other functions within the company (i.e. operations, engineering, maintenance, procurement, commercial, logistics) to ensure quality compliance is understood and adhered to for the various standards
Play a leading role in managing external audits (regulatory and customer), including responding to audit reports, identifying CAPAs and ensuring audit actions are closed out
Manage key quality processes (change control, deviation and CAPA) and coordinate the internal audit and supplier audit programmes
Lead investigations into quality critical complaints and deviations
Monitor forthcoming changes to relevant legislation to ensure ongoing compliance is maintained
Liaise with customers, external accreditation bodies and suppliers in support of product registrations and customer satisfaction
To control all existing and new product specifications and advise when changes are required
Ensure the HACCP plans are up-to-date for both SB plants, and form part of the HACCP team
Perform assessments/ audits on critical to quality suppliers
Support development and roll out of quality training across the business
Degree or equivalent in Scientific discipline (Chemistry, Biosciences, Physical sciences Degree or equivalent)
Experience of working to cGMP standards
Minimum of 3 years Quality Assurance experience gained within a pharmaceutical manufacturing environment
Hands-on experience of quality standards and systems including dealing with external auditors and certification bodies
Ability to work effectively with and influence a wide range of stakeholders (internal teams, customers, auditors)
Effective data analysis and IT skills
Effective verbal and written communication skills
Certified lead auditor Experience of CEP
Knowledge of BRC/HACCP
Knowledge of lSO9001 standard
Ability to apply chemical knowledge in practical and theoretical situations to support internal/external customers
Experienced document controller
Working knowledge of SAP
What can you expect in return?
Our people have always been at the centre of the company's success and in return for their hard work and commitment, we offer a generous benefits package including: 37 days holidays per year, inclusive of Bank Holidays, an additional paid day off each year to volunteer for a good cause in the local community, an excellent contributory Pension scheme, Life insurance, Healthcare and a range of other optional benefit schemes all within a flexible work environment.