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 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