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Dossier Compliance

5 months ago

Marlow, United Kingdom Kyowa Kirin International Full time

Overview:

- To provide Quality Assurance (QA) support for the manufacture of the Global Specialty pharmaceutical products commercialised within the EMEA Region to ensure compliance with the registered regulatory information.
- To assist with reviews of product information being manufactured and supplied to the EMEA market to ensure alignment between GMP documentation and proposed regulatory filings to support new Market Authorisation submissions and ongoing regulatory variations.
- To Provide support to the Quality Management System with elements of the Kyowa Kirin MIA

**Responsibilities**:

- Check on finished products / 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 across the EMEA region, including any current ongoing variations.
- Positively confirm regulatory compliance for each product marketed across the EMEA region and create a baseline document confirming that compliance.
- Conduct Gap Analysis on the regulatory compliance of products market within the region and where necessary facilitate the root cause analysis, deviations, CAPA’s and initiate change controls where appropriate to ensure closure of any gaps identified.
- Liaise with CMOs/Partners and Cross-Regional QA and Regulatory Affairs alongside any other stakeholders as necessary throughout the compliance check process facilitating any escalation process as required.
- To review departmental standard operating procedures (SOPs) for content and compliance with the appropriate regulatory requirements and update as necessary in line with regulatory compliance project
- Collaborate with other internal stakeholders in the development of internal procedures to complement the existing processes related to the Kyowa Kirin MIA
- Participate in the appropriate project management meetings in order to keep informed of ongoing activities, identifying and addressing any gaps relating to product quality and GMP compliance.
- Ensure that all changes to GMP documents, processes, equipment and facilities are effectively managed through the CMO and KKI change control processes in order to maintain GMP and regulatory compliance
- Participate in the internal audit (self inspection) programme so that any gaps and deviations identified in systems and procedures are addressed by the relevant department and corrective actions followed up within reasonable time scales
- To carry out staff training, including refresher training, in GxP activities, as necessary, to ensure that staff are kept abreast of current GxP regulations
- Provide regular reports of key performance indicators to QA management, as part of the Quality System, so that the appropriate resources can be allocated and corrective actions implemented, as necessary
- Provide cover, as necessary, for other QA departmental activities in order to maintain a continuity of QA service
- Participate in the review and recall of defective product, as necessary, in order to minimise patient risk

Qualifications:

- A Life Science degree or equivalent
- Excellent working knowledge of EU cGMP, especially in the interpretation of EU/UK requirements, for the manufacture, control and distribution of commercial product
- Familiarity with the structure, organisation and management of electronic CTDs.
- Sound knowledge & understanding of QC and/or manufacturing process technology for small volume parenteral (sterile / aseptic fill) products. Experience with executing reviews of batch manufacturing records would be beneficial.
- Familiar with the appropriate EU Directives and ICH Guidelines
- Familiar with Quality Management Systems e.g. ICH Q10
- Physical Requirements: (travel, lifting, typing, driving, sitting, special requirements around hours etc.)
- Occasional Worldwide travel.
- 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 might be required
- 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)
- Good interpersonal and communication skills.
- Good analytical and problem-solving skills.
- Team working.
- Working experience of Quality Systems.
- Self-starter with a good eye for detail and ability to complete tasks/objectives.
- Ability to operate in a “virtual” pharmaceutical environment.
- Kyowa Kirin Core Competencies: Results Oriented, Sense of Urgency and Flawless in Execution