12 month contract for an experienced Sr. Quality Assurance Specialist (Regulatory Compliance)
This is an exciting opportunity to work with one of the worlds leading pharmaceutical and biotechnology companies
To provide QA support for the manufacture of the Global Specialty pharmaceutical products commercialised within any affiliate of my clients group of Companies in 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.
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
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.Physical Requirements:
Occasional travel within the Region and globally (averaging 10% per year but not exceeding 20% for short periods)
As this can be a sedentary position the individual needs to be able to withstand long periods of sitting
Ability to use VDU equipment
A degree of flexibility needed with regards to rare occasions where working late/early for project team meetings on a global level might be requiredKey Competencies specific to the role
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
Please submit your CV today for further details
With over 90 years' combined experience, NES Fircroft (NES) is proud to be the world's leading engineering staffing provider spanning the Oil & Gas, Power & Renewables, Infrastructure, Life Sciences, Mining, Automotive and Chemicals sectors worldwide.With more than 100 offices in 45 countries, we are able to provide our clients with the engineering and technical expertise they need, wherever and whenever it is needed. We offer contractors far more than a traditional recruitment service, supporting with everything from securing visas and work permits, to providing market-leading benefits packages and accommodation, ensuring they are safely and compliantly able to support our clients
Product Quality Assurance