Senior Regulatory Compliance/Quality Assurance Specialist
- Experience Level
Senior QA/RA Compliance Specialist
Negotiable pay rate
Home based - UK based applicants ONLY
Job Purpose (what is this job supposed to accomplish?)
To provide QA support for the manufacture of the Global Specialty pharmaceutical products commercialised within any affiliatein this Region in compliance with the registered regulatory information.
To assist the Company with a project to ensure that each product is currently being manufactured and supplied to the marketplace in compliance with the applicable Marketing Authorisations, national legal requirements and the corporate quality and regulatory standards.
Key Responsibilities: (what are the tasks, duties and responsibilities?)
- To check the current finished product / raw material specifications, methods of manufacture, supplied artworks and analytical methods against the registered information and commitments made supporting the Marketing Authorisation for each product marketed in this Region including any current ongoing variations.
- To positively confirm regulatory compliance for each product marketed in this Region and create a baseline document confirming that compliance.
- To identify any gaps( and root cause of gaps to prevent reoccurrence) in each product's regulatory compliance, assess the impact of that gap and generate change controls, deviations and CAPAs to close that gap and return to a state of full compliance as quickly as possible.
- To liaise with CMOs/Partners and Regional QA and Regulatory Affairs as necessary.
Position Requirements (knowledge, education, qualifications, number of years' experience, etc.)
- A Life Science degree or equivalent preferably in pharmacy, process technology or advanced analytical science. Postgraduate training in regulatory affairs would be an asset.
- Fluent in technical/pharmaceutical English (written & spoken) and another language (written and spoken) that is particularly relevant to that Region.
- Experience or understanding of the registration and application process requirements (including managing variations) for pharmaceutical products, acquired specifically within regulatory affairs, quality assurance and quality control functions of a pharmaceutical manufacturer.
- Familiarity with the structure, organisation and management of electronic CTDs.
- At least basic knowledge of QC and/or manufacturing process technology for oral solid (non-sterile) and small volume parenteral (sterile / aseptic fill) products.
- Familiarity with the pharmacopoeial requirements for pharmaceutical starting materials, finished products and packaging materials.
- Around 6-8 years' experience of working within the Region's pharmaceutical industry including direct experience of working within a virtual pharmaceutical company, a manufacturing site and a research-based pharmaceutical organisation.
Key Competencies specific to the role (what traits or capabilities must they have in order to succeed, examples include presentation skills, attention to detail, capability to influence and negotiate)
- Core Competencies: Results Oriented, Sense of Urgency and Flawless in Execution.
- Interpersonal and technical communication skills
- Excellent report writing and technical writing skills
- Attention to detail and a painstaking approach to problem-solving
- Organisation and documentation management
- Cultural awareness and sensitivity
- Intuitive and investigational / problem-solving skills
- Familiarity with regulatory software, regulatory authority portals and Veeva® compliance software
If applicable to the role, outline the power granted or delegated to the role. For example power to release/recall products.
Initiation of change controls, deviations and CAPAs.
Project management and execution.
Creation of Product Regulatory Compliance Summary Documents.