Sr. Associate / Lead / Senior Lead

Provide Quality Oversight for business area(s)

• Monitor for compliance to quality system documents. Anticipates gaps and proactively proposes solutions.
• Communicates and escalates to management as appropriate.
• Ensure implementation of regional and / or affiliate Quality Plan(s) as necessary. Monitor progress of actions.
• Provide updates to quality and business owners.
• Seek and implement simplification and process improvement.
• Coordinate quality improvement initiatives.
• Review metrics and trending to improve processes and compliance, as assigned.
• Compile compliance metrics and maintain metrics process (for example, periodic report metrics).
• Analyze trends, identify areas of weaknesses / gaps and recommend corrective actions (for example, PRAC assessment reports).
• Monitor completion of deviations, change controls, CAPA, audit responses.

Audits and Inspections

• Provide support for audits / inspections (for example, preparation / readiness, coordination, back room, front room, responses).
• Communicate and ensure inspection readiness (for example, organization and availability of documents such as training records, job descriptions)
• Ensure completion of audit corrective action plans and timely resolution.
• Leads and / or supports readiness activities in collaboration with business partners.

Partnership with other area(s)

• Functions as the initial point of consultation for business areas on quality related questions.
• Partners with the business area(s) to strengthen and ensure appropriate quality controls are in place.
• Shares key learning to drive simplification and replicate best practices
• Collaborates with other quality groups as appropriate and develops quality network.
• Establishes good working relationships with assigned business area(s).
• Actively participates in team, business and quality related meetings.
• Supports issue resolution including escalation.
• Utilize a risk-based approach in guiding business areas.
• Support key projects as assigned.
• Understand the roles and responsibilities of the EU Qualified Person for Pharmacovigilance (EU QPPV), if applicable.
• Serve as an IT systems business quality assurance (BQA) representative for IT systems, as assigned.
• Perform all responsibilities of IT Business Quality as defined in Computer System Policies and Procedures.
• Review and approve as appropriate, documents associated with the development and maintenance of IT systems as the representative of MQO, Regulatory Quality.
• Partner with IT and the business on system related initiatives / changes as the BQA for assigned IT systems.

Minimum Qualification Requirements :

• Bachelor s Degree in a science / technology / health care related field or equivalent work experience
• Demonstrated ability to apply quality systems within a regulated work environment
• Effective project and time management skills
• Demonstrated ability to communicate effectively, both written and verbal, and to influence others
• Demonstrated ability to prioritize and handle multiple concurrent tasks
• Cognitive abilities which include problem solving, verbal reasoning, attention to detail, critical thinking and analytical competencies
• Strong interpersonal skills with demonstrated flexibility in varying environments / geographies
• Effective organization / self-management skills

Other Information / Additional Preferences :

• Experience in a quality control / quality assurance role
• Experience in Statistics or Data Management
• Knowledge of quality systems
• Ability to work independently and as part of a team
• Demonstrated ability to work in a global environment

Role :   Quality Consultant

Industry Type :   Pharmaceutical & Life Sciences

Department :   Quality Assurance

Employment Type :   Full Time, Permanent

Role Category :   Quality Assurance - Other

Education

UG :   Any Graduate

PG :   Any Postgraduate

Skills Required

Compliance, Process Improvement, Data Management, Analytical