Quality Ops Advisor Aprilia

Quality Ops Advisor
Aprilia
Lazio, Aprilia

With category leading brands such as Sensodyne, Voltaren and Centrum, built on trusted science and human understanding, and combined with our passion, knowledge and expertise, we're uniquely placed to do this and to grow a strong, successful business.

This is an exciting time to join us and help shape the future.

It's an opportunity to be part of something special.

Quality Ops Advisor About the role Management of operational activities and response to issues in accordance with Good Manufacturing Practices (GMP) and the company's related procedures.

Assures plant compliance for batch release and quality shopfloor for the site.

Possesses cross-functional knowledge and skills, managing operations with responsibility and diplomacy.

Can manage tasks related to project groups.

Responsible for the leadership and oversight of the following:

Ensure that the product released is manufactured and/or packaged in compliance with regulatory agencies' requirements and Haleon standards. Ensure the product is manufactured and/or packaged in compliance with GMPs through the activities of quality shopfloor requirements. Lead and support deviation response and investigations. Provide responsibility for other quality, product, and/or compliance activities as assigned. Serve as delegate/designee in absence of Quality Ops End to End Lead as needed.

Key responsibilities: Ensures Quality Systems in charge are robust, effective, and compliant with regulatory requirements, especially in the following programs and activities:

Provides leadership, resources and support to ensure that products released have been manufactured and packaged in accordance with cGMP and applicable laws. Works in decision-making autonomy related to Quality responsibilities and related to the implementation of company programs. Promptly manages any non-compliance related to process or documentation in accordance with company procedures, proposing corrective or improvement actions. He/she actively contributes to the achievement of the department's objectives by formulating proposals for improvement and optimization using the techniques and systems in use in the company. Ensure Supplier Quality practices are executed throughout the functional roles within operations. Acts as a coach or mentor to operations teams using process confirmation/audits, Gemba, training and development and reward and recognition. Communicates effectively and establishes processes to ensure smooth communication within the department, across functions and across sites. Can manage tasks related to project teams.

Participates in and proposes projects that provide for improvements in the activities of its area and plant. Know, understand and comply with all Environmental, Health, and Safety (EHS) guidelines. Qualifications and skills Essential Bachelor's degree in pharmacy, chemistry or related scientific discipline and/or 3+ years in pharmaceutical industry; Operational Quality experience/ Laboratory experience. Preferred Minimum of 3 years' management experience. Knowledge of cGMP's/FDA and other Regulatory requirements such as ICH Guidelines. Project management and leadership skills. Ability to work well under high pressure and deadlines. Must be flexible, adaptable, and a strong team player and a leader that fosters teamwork and promotes Company Values, Behaviors and Strategies. Good verbal and written communication skills required. Conflict resolution and interaction management skills required. English: good knowledge (oral and written). MS Office: good command. SAP: good command. Veeva: good command.

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