MSAT- Upstream

3 - 6 years

4 - 8 Lacs

Posted:11 hours ago| Platform: Naukri logo

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Work Mode

Work from Office

Job Type

Full Time

Job Description

  • Responsible & accountable towards safety & compliance in all the work activities in the own responsibility area(s).
  • Monitor & confirm that the established Environment, Occupational Health, Safety and Sustainability (EHSS) practices for safe work environment are followed by self & direct reports.
  • Monitor & confirm that self & direct reports adhere to the highest standards of quality, integrity & compliance for every work activity.
  • Complete the assigned trainings in a timely manner and comply with the training procedure & training calendar and monitor & confirm the same for the direct reports.
  • Attend all assigned mandatory trainings related to data integrity, health and safety measures, and monitor & confirm the same for the direct reports.
  • Participate in & support the trainings on procedures, protocols and On-the-Job activities.
  • Report nonconformities & deviations to the respective supervisor(s) and/or line manager(s).
  • Participate in & support for on-time initiation & closure of deviations, investigations, CAPA and change controls.
  • Preparation and review of TTD s, SOPs, PDRs & Protocols.
  • Review of Batch Manufacturing Records, protocol and Quality Department Protocols related to Operations.
  • Investigation of Batch failures in Operations.
  • Support in hiring process and bringing quality workforce to develop a team that is highly respected and engaged towards departmental goals.
  • Update the batch progress in PRM s and participate in client discussions.
  • Develop and implement operating methods and procedures designed to eliminate operating problems and improve manufacturing efficiency.
  • Compliance to Current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP).

Primary Responsibilities:

  • Project Ownership: Accountable for the successful execution of projects from initiation through completion, ensuring all deliverables meet client expectations and regulatory standards.
  • Quality Assurance: Responsible for ensuring that all processes comply with cGMP and other regulatory requirements, thereby safeguarding product quality and patient safety.
  • Team Leadership: Mentor and guide junior team members, fostering a collaborative and innovative environment that encourages professional growth and development.
  • Performance Metrics: Monitor and report on key performance indicators (KPIs) related to process efficiency, project timelines, and quality metrics, ensuring continuous improvement.
  • Client Satisfaction: Ensure high levels of client satisfaction through effective communication, timely updates, and proactive problem-solving.
  • Compliance and Risk Management: Identify and mitigate risks associated with technology transfer and process scale-up, ensuring that all operations are compliant with internal and external guidelines.
  • Deliver high-quality statistical analysis and reports to support process optimization.
  • Develop and validate process maps and models in collaboration with cross-functional teams.
  • Adapt to additional tasks and responsibilities as assigned, demonstrating flexibility and a proactive approach.

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