Designation/Service provider: Senior Compliance Specialist
Reporting to whom: Senior Manager Compliance and QP
Summary:
A compliance role to ensure Supplier Management and Control, Internal auditing, Local Regulatory and Market Compliance activities are performed in compliance with regulatory requirements, company policy and procedures.
Support to Supply Chain / PD /TT/ other departments to ensure onboarding/qualification / re-qualification of Suppliers and effective oversight of CMOs /Customers.
Support imported product batch release activities, including batch record review, deviation assessment, etc., to ensure batches comply with regulatory requirements and procedures.
Drive continuous improvement of systems.
Job Duties:
Leading the Vendor Notification / Complaints / Quality Defect Reporting Systems, including but not limited to the initiation of Complaints /Quality Defect Reports (QDRs)/VNs, consulting with relevant parties, leading/ participating in investigations, liaising with departments, agreeing appropriate CAPA, tracking actions etc.
Identifying and communicating to Quality leadership issues that may impact product quality, safety, efficacy, regulatory compliance, or business continuity which have arisen from a CMO / supplier or other element of the role.
QP Certification of Batches
Full review of / preparation of the Document Pack to aid the Batch Release.
Oversight of CMOs / Customers /Suppliers/Service Providers documentation
Reviewing/leading Investigations / Root Cause Analysis / Quality Risk Management exercises to ensure any such investigations are documented appropriately with relevant CAPA, if necessary.
Coordinating local regulatory activities including update/ maintenance of the Site Master File, the company manufacturing authorizations, and other relevant documents.
Management of the Supplier Quality Management System, including approval of supplier documentation, generating / reviewing Quality Agreements, co‑ordination of the supplier /vendor notification system, conducting periodic reviews of suppliers etc.
Co‑ordinating preparation for regulatory audits/corporate visits including identifying FDA 483s, performing walkdowns, leading the back room, generating / tracking readiness plans
Supporting the preparation (Redlining/Drafting /Formatting etc), review and approval of Quality System / Compliance documents as required for the Compliance Department. Documents include but are not limited to SOPs, Site Master File, Change Controls, Schedules, Product Specification Files, Deviations, Change Controls, CAPA, SOPs, Protocols, Reports etc.
Leading the company self‑inspection program by conducting audits, agreeing CAPA, incorporating inspection findings in audit execution to prevent inspection deficiencies.
Carry out and assist in any training /ongoing training of new and existing personnel as appropriate. Generate training programs related to the job function as required, etc.
Lead /participate in key Compliance Department Projects as required.
Any other duties assigned by Quality Management.
Qualifications, Technical /Soft Skills and Abilities Required:
Minimum of a bachelor’s degree in a science / quality-based discipline with a QP qualification and with a minimum of 10 years’ experience in a pharmaceutical finished drug /combination product manufacturing environment at a senior compliance specialist level, with experience as a QP on a company Manufacturing Authorisation.
Clear understanding and working knowledge of EU GMP, US FDA, Other Guidelines/ Regulations, particularly those related to Oral Solid, Sterile products, Inhalation Combination Products and excellent familiarity with Data Integrity and Good Documentation Practice requirements
Strong problem‑solving skills combined with the ability to troubleshoot.
Excellent Professional /Technical Writing Skills and computer literacy.
Strong communication, interpersonal and presentation skills (verbal / written), with an excellent command of the English language
Strong people skills, with the ability to work co‑operatively and effectively with others to establish and maintain good working relationships.
Excellent attention to detail, strong analytical thinking and the ability to work independently and as part of a team in a fast‑paced environment.
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