Sterile Manufacturing Operations Manager

3 days ago

Tiruppur, Tamil Nadu, India beBeeManufacturing Full time ₹ 10,00,000 - ₹ 20,00,000
Job Summary:

A career opportunity has arisen for an experienced Sterile Manufacturing Operations Manager to join our team.

Job Description:

The successful candidate will be responsible for overseeing the daily operations of sterile manufacturing, ensuring that all activities are conducted in alignment with company objectives. This role involves managing staff, optimizing processes, and quality management systems with high standards. The assistant manager is expected to step in and take charge in the absence of the manager, ensuring the seamless continuation of operations.

Key Responsibilities:
  • Operational Excellence: Assist in planning and execution of daily production schedules to meet operational goals.
  • Staff Management: Supervise and motivate production staff; resolve conflicts and support professional development.
  • Quality Assurance: Monitor and maintain production-related QMS elements such as Change Control, Deviations, CAPA, and Event Investigations in track-wise systems.
  • Document Management: Review and prepare production-related documents, including SOPs, BMRs, and BPRs.
  • Training and Development: Conduct training programs and evaluations on cGMP and SOPs as per schedule or Training Need Identification (TNI).
  • Troubleshooting: Troubleshoot production issues and ensure timely resolution to avoid operational delays.
  • Compliance: Ensure that all processes and documentation are carried out in accordance with SOPs, protocols, and regulatory standards.
Requirements:

To be considered for this role, applicants should possess a bachelor's or master's degree in pharmacy, life sciences, biotechnology, or a related field. A minimum of 6–10 years of relevant experience in sterile/aseptic or injectable manufacturing is required. Hands-on experience in QMS practices and compliance-driven production environments is also essential.

The ideal candidate will have knowledge of cGMP, regulatory audits, and process validations. Proficiency in handling process equipment such as autoclaves, DHS systems, PFS filling machines, mixing vessels, and packing lines is necessary. Understanding of utilities such as Diesel Generators, HT Panels, Power Transformers, etc. is also desirable.

Skills and Qualifications:
  • QMS Tools: Strong knowledge of QMS tools (Deviation, CAPA, Change Control, etc.).
  • GMP Documentation: Ability to review and draft GMP documentation.
  • Equipment Maintenance: Equipment troubleshooting and maintenance coordination.
  • Production Expertise: Good understanding of production equipment and utility systems.
  • Manpower Optimization: Capability to manage and optimize manpower deployment.
  • Reporting: Competence in generating performance and compliance reports.
Behavioral Skills:
  • Leadership: Leadership and team management.
  • Decision-Making: Decision-making and problem-solving.
  • Communication: Strong communication and interpersonal skills.
  • Time Management: Time management and ability to handle pressure.
  • Culture Fit: Continuous improvement mindset.
  • Accountability: Proactiveness and accountability.
Authority:

The successful candidate will be authorized to review, approve, and manage GMP documents within the Production department. They will also be authorized to plan and allocate production resources, including manpower distribution. Additionally, they will be responsible for executing and monitoring training programs for production and engineering teams. The candidate will coordinate with Engineering for maintenance and utility management.

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