Qa Head (baddi Location) Job in Brooks Laboratories

Roles and Responsibilities

• Heading Quality Control & Assurance department
• Audit compliance
• Responsible of Approval of quality of incumbent and outgoing material
• Handling of Quality Management System as per the regulatory guideline .
• To fulfill the resources and budgeting related to Quality department
• Review and Approval of the plant documents i.e. SOP, Protocol, report, STP, Specification, etc.To ensure the online activities related to Quality Department as per GMP and regulatory requirements.
• Review and approval deviation, Investigation,OOS,OOC, OOT and decision in coordination with other department based on impact and risk assessment. .
• Review and approval of change control and their closure.
• Accountable for Quality of products manufactured and released, monitor overall compliance of the site.
• Proactively assess quality issues at site and ensure compliance to QA regulatory requirements in manufacturing operations at site and track quality assurance metrics with site manufacturing/QC management and drive them down.
• Facilitate & Ensure all time readiness of the site for any internal and regulatory agency audits\inspections at any given point of time
• Identify and implement solution for improving existing site quality assurance systems and processes.
• Ensure that performance issues are addressed in a consistent and timely manner.
• inspections\internal audits and appropriate implementation of corrective actions regarding observations made by the agencies \ internal audit teams.
• Ensuring that findings from site audits are understood, assessed and addressed site wide in a comprehensive manner.
• Responsible for executing Quality Management Reviews at site, monitor individual Performance and set improvement areas.
• Responsible for ensuring market complaints, failures, deviations are investigated and corrective and preventive actions are implemented as per set timeline.
• Responsible for ensuring compliance to regulatory requirements on product, process and release procedures. Ensure release of safe and effective drug products from site as per cGMP requirement and regulatory commitment.
• Accountable for designing/implementing and ensuring compliance to all quality related SOPs, Policies, Standards and QA systems at the site.
• Responsible for fulfilling all training requirements of plant personnel.
• Review and approval of equipment qualification and process validation.
• Review and ensuring sterility assurance and aseptic process simulation.
• Review, authorization and release batch.
• Review and approve the annual product quality review.
• Ensuring and monitoring clean room practice and aseptic behavior.
• Performs all work in support of our Corporate Values of Pride, Accountability, Integrity and Diligence. Performs all work in accordance with all established Integrity and Diligence. Performs all work in accordance with all established Regulatory and compliance and safety requirements.
• Perform any other Activities assigned from time to time.
  

Desired Candidate Profile

Must have experience in Injectables Parenteral and Tables.