Key Responsibilities
- Responsible for monitoring Quality Management System and for constant upgradation in the existing processes through innovative ideas as per current regulatory guidance
- Facilitate regulatory agency audits(USFDA), internal and customer audits, and ensure findings from site audits are understood, assessed and addressed in a comprehensive manner.
- Support initiatives focused on quality, process and compliance improvement through close collaboration with business partners, identify opportunities for improvement and help develop strategies aimed at simplifying processes and improving quality while ensuring compliance with regulatory requirements.
- Provide technical and regulatory guidance to internal stakeholders to ensure overall quality and compliance. Ensures implementation of appropriate business processes and controls including periodic revision of Policy documents such as Quality Manual/Department manuals/Site Master File etc. in order to maintain effective quality standards.
- Site Quality Performance Metrics : To work with key stakeholders to monitor the quality related information/ data that is to be assessed as part of Site QPI’s requirements.
- Support teams for conducting investigations related to manufacturing and laboratories. Ensure effective, intelligent data analysis techniques are used to determine the true root cause of issues and derive the appropriate CAPA actions.
- Support Quality Operations across the organization by, ensuring QAIP processes and activities related to manufacturing, packaging and Warehouse areas are fully implemented and effective.
- Co-ordinate with Production teams to ensure Shopfloor compliance to GMP and regulatory requirements
- Ensuring batches are manufactured and packaged in accordance with cGMP and requirements and Marketing Authorization.
- Support review and approval of Master batch records including the final review of executed batch documents and submission.
- Review and approve deviation, investigations, change controls in Track wise system and act as the Quality Management approver for Investigation, CAPA, Temporary changes etc. as required.
- Review, evaluate and approve trend reports for QMS elements such as Deviations, CAPA, market complaints and Temporary changes.
- Provide direction and support to improve the activities under Quality System: QMS Trackwise which includes:
- Deviations, CAPA, Change controls, Temporary changes, Market complaints
- Artwork management and approval process.
- Supplier Qualification Program for the organization including authorization of Quality Agreements.
- Alignment of Site procedures with Global policies and procedures.
- Analytical Quality Assurance
- Certification programs and GMP Training program
- Provide direction and support to improve activities under Quality Validations and Qualification programs , and approve associated documents such as,
- Validation and Qualification programs
- Process /Cleaning validations
- Building and Utilities Qualifications
- Equipment Qualifications
- Calibration and PM programs
- Oversee activities related to Documentation control: Issuance, Archival, retrieval and updation of documentation activities as per regulatory compliance and Reserve sample management.
- Responsible for review and approval of Quality Risk Assessments and reports.
- Reviewing and updating employee development plans, ensuring that all employees are properly trained and qualified to execute their duties
Candidate Profile
Key Skills
- Possess sound knowledge in Quality Management System which comprises of Change controls, deviations, LIRs, CAPA.
- Experience of facing, managing and responding to USFDA audits.
- Possess sound knowledge in Process validation, cleaning validation and qualification of equipment, facilities and utilities.
- Hands-on experience in Trackwise application, SAP etc.
- Technical expertise in drafting and reviewing GMP compliance policies, procedures, Quality Agreements etc.
- Maintains good Interpersonal skills, possesses good leadership qualities and communication skills.
- Strives to drive projects related to Quality Assurance effectively.
- Works effectively towards ensuring the availability of adequate QMS roles across departments by organizing timely training sessions to support business operations.
- Monitor the GMP induction program and ensure that all personnel working in GMP areas inclusive of Lab functions are trained on the GMP courses as part of induction training & continual refresher training.
Qualification & Experience
- Master’s Degree in Science or Pharmacy
- Minimum 20 years of experience in Quality Assurance in GMP regulated Pharmaceutical companies with USFDA approved sites
