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Position: Head – Quality Control
Location: Toopran Mandal, Andhra Pradesh, India
- Manages all the aspects of Quality Control Operations (chemical and microbiological lab) of Insulin plant, MRP, ensuring that testing activities are performed compliantly with all regulatory requirements. (EU approved laboratory)
- Is accountable for providing scientific and technical guidance on all laboratory matters. Is accountable to provides key leadership, vision, and direction to the QC Operations while providing operational expertise and excellence in the area of Laboratory Controls.
- Is responsible for both short and long-term strategies.
- Ensure the continuous laboratory compliance in the Microbiology and Chemistry Laboratory in line with current regulatory requirements.
- Ensure full-time audit readiness (including EU) of the QC labs. Is responsible for the high performance of QC lab activities, on-time delivery, budget preparation and control, resources optimization, maintenance management, equipment qualification.
- Develop and maintain a mindset and methodology of continuous improvement.
- Ensure the action plan set up and follow up. Is responsible for the people’s development within the perimeter.
- Is responsible for the Health, Safety, and Environment of the employees and installations.
Duties & Responsibilities
- Manage human resources and ensure people development of his/her team members
- Evaluate and manage resources (Chemistry lab and Micro lab) to ensure smooth operations, performance, and full-time inspection readiness
- Manage resources planning and delivers expected output
- Managing team of QC lab managers and QC professionals
Quality systems and documentation:
- Is the SME for GMP Directives and guidance
- Actively influencing the development and formalization of corporate laboratory control standards, policies
- Managing, reviewing, creating, and maintaining relevant Quality and safety programs, documents, and their practice.
- Implementation and monitoring of global systems and documents.
- Monitoring laboratory equipment performance by establishing quality standards; developing operations, quality, and troubleshooting procedures; ensure staff compliance; ensure compliance to cGxP.
- Effective management and strong involvement in the investigation of OOS, deviations and provide effective CAPA plan.
- Approval of Quality control test results and give authorization for the release or reject the analytical test as per approved specifications.
- Maintenance of laboratory information system by identifying information needs and problems, entry of sample and test information into laboratory database; recommending improvements; establishing priorities; testing; training employees; maintaining security and confidentiality.
- Monitoring schedules for sampling, testing, and reporting
- Monitoring a clean and hygienic environment in the laboratory and other workspaces.
- Organize laboratory instrumentation servicing and calibration as per schedule or manufacturer’s instructions.
- Develops budget for the laboratory and maintains control of lab costs.
- Completes operational requirements by scheduling and assigning employees; following up on work results.
- Enforces laboratory safety procedures and consults with HSE about these issues.
Knowledge, Skills & Competencies / Language
- Proven ability to cooperate transversally
- Proven ability to Act for Change
- Ability to lead teams with good interpersonal skills
- Excellent communication skills
- Well-structured way of working / thinking
- Language requirements: advanced English skills
- A minimum of Bachelor’s Degree or Masters in Science or Pharmacy is required.
- Minimum of 12 years of relevant experience in similar senior management roles/positions. At least 3-4 yrs in senior management roles(QC or QA)
- The pharmaceutical industry with injectable platform / sterile formulations/biopharmaceutical experience is a plus
- Demonstrated experience in managing global regulatory compliance, continuous improvement initiatives, partnering with Operations for enhanced inspection readiness, and proven/qualified Quality system management techniques.
Requirements of the job
- This position requires a well-structured way of working
- This position requires excellent communication skills within the site and on a global level
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