Assistant Manager Production

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:

• Bachelor's or master's 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 accountability.

Authority:

• 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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Biotech is an equal opportunity organization promoting diversity while ensuring no discrimination on any ground, including gender, race, religion, age, sexual orientation, disability, etc.