Quality Coordinator - Computerized Systems Specialist

You’ve built experience, now use it where bold ideas meet real impact. At Opella, we’re challenging how self-care works for millions of people and need leaders and experts ready to shape what’s next. As a Quality Coordinator, you’ll bring your skill, your curiosity and your drive to make health simpler, smarter and more human. 

About the job:  

Reporting Line:

This position will report directly to Quality Systems and Technical Support Lead.

Role Impact : 

Supporting the consistent application of quality requirements in the processes within M&S Virginia. 

Scope: 

The role holder will work closely with colleagues within Quality, Production, Warehouse, Engineering, Planning and may also be responsible for other activities within the scope of Quality Virginia. 

Mission & Tasks:

The Quality Coordinator (QC) shall assist and support the Site Quality Head in relation to the efficient, effective and compliant execution of quality assurance activities to ensure that the site maintains compliance with the code of Good Manufacturing Practice for Complementary Medicinal Products.

The QC shall assist in the establishment and continuous development of a robust Quality System of an appropriate standard. The QC shall participate in site wide Quality observations with a key focus on continuous improvement and efficient compliance.

The QC role may include a combination of the following activities, which are further outlined in role priorities:

Computerized System Specialist

The QC – Computerized Systems Specialist, reporting to the Quality Systems and Technical Support Lead, shall support the Quality Assurance department to provide effective and compliant advice and support with respect to computerised systems, data integrity, and other validation, qualification and technical support activities. These responsibilities include:

• Compliance with in scope Opella Global documents related to Computerised Systems and Computer Systems Validation (CSV), and also with local regulatory requirements
• Develop and maintain a team based, collaborative work environment.
• Identify best practices throughout site operations, including data handling, data integrity and review.
• As need arises, assist with validation related activities for computer systems, spreadsheets, processes, equipment, facilities, HVAC, utilities and cleaning procedures
• As need arises, assist with calibration management for plant equipment and instruments

Priorities

• Ensure that activities are performed in compliance with related regulations by strictly adhering to GxPs, GQ (Global Quality) documentation, including HSE (Health, Safety and Environment) procedures.
• Comply with agreed timelines for development and validation as required. Complete allocated tasks correctly on time, proactively communicate delays as appropriate and work productively, efficiently and effectively.
• Produce Protocols, Reports and other documentation as required, pertaining to the project.
• Provide support and advice to local GxP Computerised System owners
• Maintain inventory of GxP Computerised Systems
• Assign GxP risk classification for Computerised Systems
• Maintain validated state of GxP Computerised Systems including documentation writing (protocols, reports)
• Perform periodic Reviews for GxP Computerised Systems
• Effectively communicate technical and general issues to the Quality Systems and Technical Support Lead in a timely fashion.
• Participate in internal/global quality/regulatory audits, as required.
• Contribute to reduction wastage/costs (e.g. time, stocks, and product) by improving analytical and plant Right First Time. Actively participate in continuous improvement activities.
• Adhere to GMP and GLP standards.
• Adhere to SOP’s, OPEs and other written instructions.

 Health, Safety and Environment

• Take reasonable care of the health and safety of yourself and others.
• Cooperate with Opella management in the provision of a healthy and safe workplace.
• Identify and correct unsafe conditions or behaviors and immediately notify the Manager of any serious incidents; complete an Incident / Injury Report and forward to Human Resources within 48 hours where necessary.
• Undertake duties in accordance with the current Opella Policies and Procedures.
• Report non-conformance in accordance with the requirements of the Opella quality system.

Scope of Responsibility   

Latitude of Action:

• The role holder must work aligned with the Quality Systems and Technical Support team.
• The role holder has developed quality mindset and follows Global Quality Policy, Standards and Processes as well as specific local requirements.

Role Impact:

• Supporting the consistent application of quality requirements in the processes within M&S Virginia.

Scope:

• The role holder will work closely with colleagues within Quality, Production, Warehouse, Engineering, Planning and may also be responsible for other activities within the scope of Quality Virginia.

About you: 

Experience:

• An understanding and working knowledge of cGMP, as it relates to Complementary Medicines
• Superior Attention to Detail
• Quality Systems experience in a highly regulated GMP environment.

Skills:

• Competence in the delivery and execution of Quality systems
• Proven problem-solving ability and the ability to understand, assess and evaluate risks associated with complex processes related to cGMP activities.

Languages:

• English

This is more than the next step in your career, it’s a chance to lead change and help reinvent self-care for the world. If you’re ready to challenge, inspire and deliver impact that matters, we’re ready for you. We are challengers. We are Opella. 

About Us: 

Opella is the self-care challenger with the purest and third-largest portfolio in the Over The Counter (OTC) & Vitamins, Minerals & Supplements (VMS) market globally.   

Our mission is to bring health in people’s hands by making self-care as simple as it should be. For half a billion consumers worldwide – and counting. 

At the core of this mission is our 100 loved brands, our 11,000-strong global team, our 13 best-in-class manufacturing sites and 4 specialized science and innovation development centers. Headquartered in France, Opella is the proud maker of many of the world’s most loved brands, including Allegra, Buscopan, Doliprane, Dulcolax, Enterogermina, Essentiale and Mucosolvan.  

As a globally certified B Corp company, we are active players in the journey towards healthier people and planet. Find out more about our mission at www.opella.com.