Quality Manager and Responsible Person (Ireland)

at  Sandoz

ESSENTIAL REQUIREMENTS:

• Life science degree level or equivalent experience in the pharmaceutical industry, GxP knowledge
• >3 years Experience in the pharmaceutical industry operating as a Responsible Person
• Detailed knowledge of GMDP requirements relating to manufacturing, packaging, licensing, release and post-market responsibilities.
• Knowledge of process improvement techniques.
• Good working knowledge of problem solving and evaluation techniques.
• Development of quality systems and/or processes
• Coaching/training/facilitation
• Good level of skills in the use of computer based systems and applications
• Relevant knowledge and experience related to the distribution of medicinal products
• Knowledge of products traded under the license and access to pharmaceutical knowledge and advice when it is required
• Relevant knowledge and experience related to the distribution of medicinal products

YOUR KEY RESPONSIBILITIES:

Your responsibilities include, but not limited to:

• Leading local execution of quality systems including compliance to GxP requirements (requiring knowledge of regulations), global standards/SOP’s and local work practices, Responsibility for monitoring compliance of the quality activities/systems owned locally – including metrics, quality review and self-inspection. Liaise with global quality system owner and where appropriate participate in expert networks or work with Centres of Excellence.
• Perform routine risk/impact evaluations associated with product based decisions or the quality system and participate in escalation situations
• Ensure local compliance with global standards/SOP’s and maintain relevant local SOP’s. Communicate requirements and/or changes and act as content expert for audits and inspections using knowledge of associated system.
• Ensure efficient information flow and effective communication of all relevant quality matters within the country organisation, from the country to the Global QA organization and vice-versa including but not limited to issue escalation
• Develop and recommend changes for productivity and quality improvements. Lead in implementation of quality initiatives & continuous improvements including project planning, milestone delivery and communication within the team and cross functionally.
• Perform tasks related to quality compliance/governance depending on individual experience. This could involve product launch evaluations, product divestments, quality oversight, MAH responsibilities, regulatory updates, development of documents such as site master file or business continuity plan, metrics review, quarterly leadership presentations or acting as a single point of contact for e-compliance, data integrity, document management
• Work with the country organisation business franchises/brands to provide direction and support for all quality / GMP matters. Provide GxP education and training to others in the team and across the CO. Act as a role model for Sandoz Values and Leadership Behaviours, taking positive action to strengthen quality culture and awareness
• To personally fulfil the duties of the Responsible person defined by Irish Health Authority (HPRA). The responsibilities, knowledge, experience and duties of the responsible person as defined by the HPRA
• Ensure all GDP operational activities are maintained and continuously improved in accordance with all internal guidance and external regulations
• Maintain an awareness and understanding of the required legislations and Sandoz Quality System, implementing legislation and Sandoz Quality Standards and Quality Directive within GDP activities and supply chain processes.
• Oversee activities in the event of a product Recall and mock recall
• Understand the role of the professional bodies and organisations that regulate those supplying medicinal products to the public e.g. GPhC and role of home office in relation to handling of controlled drugs
• Ensure all GDP operational activities are implemented, maintained and continuously improved in accordance with all internal guidance, external regulations (MRA) and in line with best practice. Keep up to date with changes/ updates in legislation via Health Authority websites and/or newsletters, and any directive regulations or guidelines.