Biotech - Assistant Manager - Production

2 days ago

Ahmedabad, India Biotech Healthcare Full time

About The Job
ROLE OBJECTIVE:

  • A key objective of this role is to oversee the daily operations and ensure 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.

Role & Responsibilities

  • Assist in planning and execution of daily production schedules to meet operational goals.
  • Supervise and motivate production staff; resolve conflicts and support professional development.
  • Monitor and maintain production-related QMS elements such as Change Control, Deviations, CAPA, and Event Investigations in track-wise systems.
  • Review and prepare production-related documents, including SOPs, BMRs, and BPRs.
  • Conduct training programs and evaluations on cGMP and SOPs as per schedule or Training Need Identification (TNI).
  • Troubleshoot production issues and ensure timely resolution to avoid operational delays.
  • Ensure that all processes and documentation are carried out in accordance with SOPs, protocols, and regulatory standards.
  • Maintain accurate and up-to-date records such as batch records, equipment logs, and quality reports.
  • Generate and submit reports on production performance, efficiency, and quality metrics.
  • Coordinate with the maintenance team to ensure timely resolution of equipment breakdowns.
  • Oversee the document control process to ensure integrity and accessibility of quality records.
  • Liaise with cross-functional departments to facilitate seamless production activities.

Desired Candidate Profile

  • Bachelors or masters degree in pharmacy, life sciences, biotechnology, or a related field.
  • Minimum 6-10 years of relevant experience in sterile/aseptic or injectable manufacturing.
  • Hands-on experience in QMS practices and compliance-driven production environments.
  • 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.
  • Understanding of utilities such as Diesel Generators, HT Panels, Power Transformers, etc.

Functional Skills Required

  • Strong knowledge of QMS tools (Deviation, CAPA, Change Control, etc.
  • Ability to review and draft GMP documentation.
  • Equipment troubleshooting and maintenance coordination.
  • Good understanding of production equipment and utility systems.
  • Capability to manage and optimize manpower deployment.
  • Competence in generating performance and compliance reports.

Behavioral Skills Required

  • Leadership and team management.
  • Decision-making and problem-solving.
  • Strong communication and interpersonal skills.
  • Time management and ability to handle pressure.
  • Continuous improvement mindset.
  • Proactiveness and Authorized to review, approve, and manage GMP documents within the Production department.
  • Authorized to plan and allocate production resources, including manpower distribution.
  • Authorized to execute and monitor training programs for production and engineering teams.
  • Authorized to coordinate with Engineering for maintenance and utility management

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