The Bradford site is accredited for both current Good Manufacturing Practice (cGMP) and Good Laboratory Practice (GLP) for physical and chemical testing and is also FDA inspected. Work at the site focuses on the development and establishment of a wide range of analytical methods (bespoke, monograph, generic, in-house) across diverse techniques, for customers from the Life Sciences and related industries. This may be followed by verification / validation of the methods and subsequent release testing and stability studies. Sample types include active pharmaceutical ingredients, raw materials, finished dosage forms, wound dressings, implants and others.
The Quality Assurance Officer’s function is the independent current Good Manufacturing Practice (cGMP) review and approval of the work conducted at the Bradford, as required by the regulatory guidelines employed. Bradford’s sister site at Sandwich undertakes cGMP API manufacture; the role holder will work closely with QA colleagues at Bradford and Sandwich to oversee the analytical aspects of this work from a QA point of view. As the Bradford site also conducts work to Good Laboratory Practice (GLP) regulations this role will have the opportunity to cross train in GLP auditing.
Main Duties to:
All responsibilities and duties refer to Concept Life Sciences, Bradford, and to cGMP compliance, unless otherwise stated.
- Will carry out routine checking, review and approval of cGMP laboratory reports, data summaries and COAs.
- Will carry out routine checking, review and approval of performance verifications, validation protocols, method transfer protocols and appropriate reports.
- Will carry out routine checking, review and approval of laboratory and project notebooks.
- Will support activities associated with Change Control, Equipment Qualification, Non-Conformances, OOS / OOT and Exception Reports.
- Control of site archiving facility, archiving and retrieval of records
- Will write and review quality assurance-related standard operating procedures.
- Will assist in managing the document control system by maintaining database records, reviewing and approving controlled documents (SOPs, policies, proformas), activating documents, assessing upcoming documents due for review, informing staff by email of revised documents.
- Report all audit findings to the QA Manager and site management (as applicable). Manage / track any resulting non-conformances or recommendations.
- Schedule and conduct internal and external audits, generating audit reports and following-up action points.
- Train other personnel in all aspects of quality assurance systems and procedures as required
- Advise management of any deficiencies in regulatory requirements
- host or partake in client and regulatory visits as appropriate
- Liaise with site personnel to ensure a full understanding of regulatory requirements.
- Perform administrative tasks as required.
- BSc or similar in an analytical, chemical or related scientific field.
- Some experience of quality assurance experience, preferably focusing on cGMP for API or finished product.
- Consideration will be given to applicants with less experience who have multi-year experience of working in a cGMP analytical environment and wish to development their career in QA.
- Consideration will also be given to applicants who have focused on Regulatory GLP, including GLP auditing.
- Able to identify and highlight own training needs, and proactively upskill.
- Strong written and oral communications skills; IT Literate.
- Excellent attention to detail, proactive approach; ability to multi-task and prioritise workloads.
- Role is subject to probation and training on internal processes.
- Full time 37.5hrs/week. Flexibility is required, some weekend work may be needed and earlier or later start / finish times may also be required to ensure cover on site.
- There may be the opportunity to work across the company’s other laboratory sites.
We offer a range of learning and development opportunities depending on the role, with all employees having access to a range of internally delivered training modules as standard. In addition to a competitive salary, we offer as a minimum: Pension scheme, Share Save scheme, Healthcare Cash Plan, Retail Discount scheme, Cycle to Work scheme, Childcare Vouchers, Discounted Gym membership rates and local Reward & Recognition schemes.