For one of our clients we are looking for a QA & Regulatory Consultant.
- Can you plan your own work?
- Are you capable of working in an international environment?
- Are you available to travel?
Then you might be the candidate we are looking for! Don't hesitate to apply now!
For our client we are looking for an independent senior Regulatory Writer or QA Officer to manage, support and provide the required oversight of data verification for the Ebola dossier MAA filing. This consultant will be responsible for performing data verification on the technical eCTD sections to support Regulatory CMC dossier applications. Represents the department on multi-functional project development teams to support regulatory filings.
Evaluates and ensures the completeness, accuracy, and compliance of data provided for all regulatory submissions. Ensures all Quality submissions are completed in a timely manner.
This position is needed due to the extra capacity that is needed to support of the Ebola vaccine fast track regulatory filing in 2019.
- Supports dossier strategy / product development plan creation at a compound level
- Interfaces directly with CMC/Tech team members, Regulatory, JSC, external service providers and internal VPAD/PDMS customers such as GCO and TA.
- Interfaces mainly internal functional stakeholders, some external stakeholders
- Influences or persuades others to accept new ideas, approaches or concepts or gains alignment on divergent issues
- Manages complex projects with accelerated priority
- Resolves cross-functional issues
- Appropriately identifies and manages key stakeholders, and escalates when needed to obtain senior management support.
- Carry out data verification related to the regulatory filing
- Review of Master Production Records and test instructions;
- Review of Batch Production Records and test results;
- Review of documentation related to process validation, technology transfer, raw materials, product descriptions and specifications, shipments, labelling and traceability (lot genealogy);
- Interfacing CMO’s;
- Carry out all QA duties related to external manufacturing like: Review and approval of documentation related to process validation, technology transfer, raw materials, product descriptions and specifications, shipments, labelling and traceability (lot genealogy);
WORKING RELATIONSHIPS AND CONTACTS
Communicates routine aspects of filing with professional staff across departments including Vaccine Process & Analytical Development (VPAD), both within and outside the site.
The successful candidate needs to build a strong relationship with the functional areas within VPAD and create a fixed first-point-of-contact regarding data verification topics.
- Plan own work;
- Assesses compliance with regulations on difficult technical issues;
- Maintains data verification records in an accurate and timely manner;
- Addresses issues that may not be immediately evident by using existing team structures;
- Refers extraordinary situations to manager for final approval;
- Leads project teams in identifying and eliminating risks;
- Independent, mature attitude and capable of making judgments appropriate to job level;
- Capable of working in an international environment;
- Availability to travel;
- Insight into the manufacturing processes of vaccines and proteins and into the analytical methods used for characterizing such products;
- Thorough knowledge of international guidelines on GMP and preferably on GCP
- Minimum MSc University Degree
- Minimum 5 years relevant QA or Regulatory experience
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- Full time preferred, minimal hours 24
- Minimal presence on-site 60%
- Initial term 3 months, extension is a possibility