Production Compliance Expert- VI & P

Job description

Mission statements

Ensures compliance of established operational processes in visual inspection and packing with global quality and HSE guidelines using QMS and SMS tools and focus on corrective actions and continuous improvement to optimise and sustain the high quality level of all the activities in the area of responsibility. 

This role is within Visual Inspection and Packing, Insulin Plant, MRP budget.

Duties & Responsibilities

Roles within Production

·  To supervise, motivate and allow his team personnel to develop his/ her competencies and potential in order to perform his/ her job better.
·  To support and implement continuous improvements within his/her perimeter.

Operations

·  Initiate change controls, carry out investigations and lean management and several miscellaneous activities related to processes or process equipment pertaining to VI and Packing areas
·  Improve the existing facility in terms of equipment and practices in compliance with site quality procedures and evaluate the risk analysis for equipment and processes.
·  Responsible for timely support in execution and documentation of validations and other relevant activities.
·  Works closely with validation team to execute the (re)validation and (re)qualification activities as per the pre-approved protocols.
·  Supervises and coordinates validation activities in VI and Packing areas.
·  Responsible for preparation of SOPs, batch production records and relevant documents pertaining to VI and Packing including Medical devices.
·  Act as a key point of contact for internal and external audit preparations.
·  Simplify ways of working.
·  Supervision that documentation is duly executed.
·  In-line with APU concept, take decisions in given boundaries to meet business requirements.

Training

·  Develop training concept, Train the staff or ensure their training on visual inspection and packing operations as per Sanofi group strategy.
·  Acquire relevant equipment and process training with respect to visual inspection and packing   relevant operations.
·  Prepare the team for various regulatory inspections/ audits and GMP compliance.

Cross functional

·  Act as an interface between department and other cross functional teams to investigate and resolve quality related issues in VI and packing areas.
·  Responsible for co-ordinating with QA, QC, Validations, Engineering, HSE and Projects to support in respective relevant activities.
·  Support activities conducted by cross functional departments such as HSE, Operation Excellence, lean management and facilitate exchange of information.
·  Escalate the potential quality events to superiors and take part in investigations and root cause analysis.
·  To coordinate with projects and engineering department during commissioning, qualification and maintenance activities.
·  Plays a critical role in ensuring technology transfer to VI and Packaging.

HSE

·  To identify, correct and promptly report unsafe conditions, behaviours, or potentially hazardous situations.
·  To animate a strong, proactive culture oriented towards promoting positive behaviours at all times.

Knowledge, Skills & Competencies / Language

·  A strong knowledge of GMPs related to visual inspection and packing in both domestic and international regulatory environments is required.
·  Excellent and detailed knowledge of qualification and handling of instrument and equipment related to visual inspection and packing area is prefered.
·  Strong organizational, interpersonal and excellent communication skills are essential.
·  Working knowledge on computer, Microsoft word, excel and power point
·  LEAD competencies:
·  Act for change: Adapt to changing circumstances in positive and enthusiastic manner.
·  Cooperate Transversally: Develop and maintain effective cross functional working relationships and partnerships.
·  Develop people: Share best practices and expertise to improve team member’s competencies.
·  Capacity to imbibe new technologies.
·  High levels of confidence and problem solving capabilities.
·  Language requirements: Fluency in English (reading, writing and listening).

Qualifications

·  Qualification: Minimum of Bachelor’s degree in applied sciences.
·  Minimum of 6 years’ experience.
·  Pharmaceutical industry experience is a must.

Requirements of the job

·  This position requires adapting well to new and advance equipment and quality systems.
·  The Incumbent should be able to work in shifts in exceptional cases.

At Sanofi diversity and inclusion is foundational to how we operate and embedded in our Core Values. We recognize to truly tap into the richness diversity brings we must lead with inclusion and have a workplace where those differences can thrive and be leveraged to empower the lives of our colleagues, patients and customers. We respect and celebrate the diversity of our people, their backgrounds and experiences and provide equal opportunity for all.