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* Co-ordinating the Complaints / Quality Defect Reporting Systems
* Consulting with relevant parties, leading/participating in investigations, agreeing appropriate CAPA, etc.
* Identifying and communicating to Quality leadership issues that may impact product quality, safety, efficacy, regulatory compliance, or business continuity arising from a supplier or other element of the role.
* Reviewing/leading investigations, root cause analysis, and quality risk management.
* Ensuring investigations are documented appropriately with relevant CAPA, if necessary.
* Co-ordinating local regulatory activities, including updating and maintaining the Site Master File.
* Managing the Supplier Quality Management System, including conducting supplier audits, reviewing documentation, generating/reviewing Quality Agreements, and coordinating supplier notifications and periodic reviews.
* Preparing for site regulatory audits, including managing the audit process, collating responses, and implementing CAPA.
Experience/Requirements
* Bachelor’s degree in a science or quality-related discipline.
* At least 10 years of experience in a pharmaceutical finished drug product manufacturing environment, with knowledge of EU GMP, US FDA, and other regulations.
* Excellent understanding of current and pending EU GMP and US FDA regulations.
* Strong communication and presentation skills (verbal and written).
* Self-starter with advanced organizational skills and attention to detail.
* Strong interpersonal skills to work effectively with others and maintain good relationships.
Remuneration Package
Salary is negotiable depending on experience.
About the Position
Key Responsibilities
* Co-ordinating the Complaints / Quality Defect Reporting Systems
* Leading/participating in investigations and agreeing CAPA.
* Communicating issues impacting product quality, safety, efficacy, regulatory compliance, or business continuity to Quality leadership.
* Reviewing and leading investigations, root cause analysis, and risk management.
* Documenting investigations with appropriate CAPA.
* Managing local regulatory activities, including updating the Site Master File.
* Managing the Supplier Quality Management System, including audits and documentation review.
* Supporting regulatory audit readiness and responses, including CAPA.
* Supporting QP certification activities, such as batch record review and product specification maintenance.
Experience/Requirements
* Bachelor’s degree in a science or quality-related discipline.
* Minimum 10 years’ experience in pharmaceutical manufacturing with knowledge of EU GMP, US FDA, and other regulations.
* Excellent knowledge of current/pending EU GMP and US FDA regulations.
* Strong communication and presentation skills.
* Organized, detail-oriented, and proactive.
* Effective collaborator with strong interpersonal skills.
Remuneration Package
Salary is negotiable depending on experience.
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