Manager - Quality Excellence & Validation

3 days ago

Jhagadia, India Abbott Full time
Primary Objective:
• This role is to support the Quality function, driving Operational Excellence in collaborating with multiple stakeholders to drive a culture of systematic Quality management and continuous improvements aligned with Abbott strategy and objectives.
• To manage, review and improve of Quality and Food Safety requirements through “Excellence culture"
• The job holder accountable for driving the Projects of Quality department and ensure on-time delivery as expected
• Review and Manage all the activities of Validations, Change Controls, Plant scale trials for new product development,
• Quality MIS and Implementation of Validation Master Plan at Jhagadia site in order to meet the ANI QMS requirements
Major Responsibility:
Evaluating, ideating, conceptualizing and driving strategic initiatives and projects.
• Identify failure modes in current processes and work closely with stakeholder teams to solve the chronic problems and finding long term solutions
• Driving continuous improvement in efficiency, Cost and effectiveness of processes
• Drive Statistical Process Capability/ 6 Sigma / Quality Circle to drive continual improvement in Quality and Food Safety compliances
• Champions project governance and execution of assigned projects
• Ensures risk assessments are completed and that contingency plans are identified and executed
• Support the team in the improvement of the quality and the process improvement initiatives
• Delivery through matrix management systems and driving a culture of continuous improvement.
Responsible for providing QA inputs for trials on process/ Product.
• Responsible for Design Qualification, Operational Qualification, Installation qualification, Process qualification at Jhagadia site and ensures all necessary validation activities are planned and executed according to plan
• The Validation manager is responsible for reviewing the validation protocols and test procedures to ensure all products meet with regulation requirements. A broad based role that works with process, equipment, facility, analytical method, cleaning, and computer system. Role requires management, review and approval of change control and prepares training materials on validation programs.
•To review the validations activity during installation of plant and machinery at the site. Ensures facility, Process Equipment, Cleaning, Lab equipment & test methods are validated before commercial production
• Maintenance of Documentaion of all validation reports
• QA MIS data compilation & coordination with the concerned departments for taking the corrective/ preventive action.
• To implement the Master Validation Plan at the Jhagadia site.
• To maintain the records of all above activities to meet the Quality audit requirements.
• To execute the validation activities of computerized system with coordination of engineering, manufacturing and I.T departments.
• To manage all initiatives associated with the GQP, GQMP & Quality policy, EHS & compliance at site.
• To support in preparation of Opex & Capex budgets for QA function, making the proposal and close follow-up of execution of new and exisitng projects .
To support the QA CIP projects .
• Impart training to all stake holders regarding validation and compliance and enhance understanding of V and C
• Ensure all the requirements as per the QMS elements and implementing the updated requirements in Quality Assurance to improve & sustain the systems.
Education: Post Graduate Degree in Pharma/ Dairy or Food Sciences or related field like Master’s Degree in science with 10 to 12 years of experience in quality control or quality assurance function.
Background:
Understanding of Quality systems ISO 9001/ISO 22000/ FSSAI /BIS / Risk Assessment, conducting Internal Audits and exposure for HAZOP/HACCP/Food Safety systems is desirable.
• Knowledge of regulatory, statutory and corporate policies
• Experience in Project management.
• Effective interpersonal and communication skills.
• Ability to work independently and manage assigned responsibilities and projects.
• Adaptability, Innovation, Initiative, Teamwork, Integrity
• Interpersonal skills in order to have healthy relationship with colleagues working in different functions at site.
• Communication skills in order to understand and provide necessary feedback or solutions within the QA team and internal customers.
• Sense of urgency in planning, coordinating of compliance function so as to ensure all applicable corporate, division policies, regulatory, statutory and food safety requirements are adhered to.
Ability to operate and calibrate all lab equipments.
•Ability to accurately operate and calibrate all QA analytical equipments. Ability to implement site Validation Master Plan in order to validate the manufacturing Process, Installation and Cleaning of •Equipments & methods.

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