Deputy Manager Manufacturing Documentation

Amneal Pharmaceuticals LLC; Dahej; On-site; INR 900,000 - 1,500,000; Full time

Job summary

Amneal Pharmaceuticals LLC in Dahej, Gujarat is seeking a shift supervisor to oversee and direct production staff across API manufacturing stages. The role emphasizes GMP adherence, documentation accuracy, and coordination with QC, ADL, and Engineering to maintain quality and schedule adherence.

The ideal candidate has 8+ years in GMP settings, with strong experience in batch records, SOPs, and deviations handling. A BSc is required, MSc preferred, and SAP/ERP familiarity is a plus.

Qualifications

• Bachelor's degree in science is required.
• 8+ years in GMP manufacturing environments.
• Experience with batch records and QA/documentation.

Responsibilities

• Oversee and direct shift operations.
• Ensure GMP compliance and accurate documentation.
• Coordinate with QC, Engineering, and ADL.
• Lead training and performance reviews.
• Manage deviations/CAPA and change controls.

Skills

Shift supervisor

GMP compliance

Documentation control

Batch record management

Stakeholder coordination

Education

Bachelor's Degree in Science (BSc)

Master's Degree in Science (MSc)

Tools

SAP

ERP systems

Job description

JOB DESCRIPTION

Overseeing and directing the work of operators, technicians, and other staff members during the shift

Description

• Overseeing and directing the work of operators, technicians, and other staff members during the shift
• Participating in shift scheduling and planning to ensure appropriate staffing levels and resource allocation.
• Conducting seamless shift handovers by sharing critical information with the incoming shift, including updates on ongoing processes, issues, and maintenance requirements.
• Maintaining accurate records and documentation of production activities, including batch Manufacturing Record (BMR), Batch Cleaning Record (BCR), Batch Packing Record (BPR) records, Equipment's usage logs and Deviation reports if any.
• Ensuring that the API/Intermediate production processes adhere to Good Manufacturing Practices (GMP) and other quality standards. This involves monitoring and maintaining the quality of products being manufactured.
• Ensuring effective communication with other departments, such as quality control (QC), Analytical Development Lab (ADL), Engineering etc. to facilitate the coordination of all plant activities.
• To perform and verified equipment before and after use as per Equipment Cleaning Record (ECR).
• Addressing and resolving operational issues and equipment malfunctions that may arise during the shift. This may involve coordinating preventive maintenance, calibration etc. activities to minimize downtime.
• Continuously monitoring the various stages of API manufacturing, such as reactions, purification, filtration, and drying, to ensure they are running as per the prescribed procedures.
• To coordinate in investigating the non-conformance of the product with concerned Department.
• Conducting performance evaluations and providing feedback to shift personnel, as well as identifying and addressing training and development needs.
• Providing training and guidance to shift staff, assisting them in developing their skills and knowledge in API production.
• Meeting or exceeding production targets by managing and optimizing production processes, equipment, and resources.
• Identifying opportunities for process optimization, efficiency improvements, and cost reduction. Implementing changes and reporting results.
• Ensuring that all safety norms, regulatory requirements, and standard operating procedures (SOPs) are followed rigorously. This includes conducting safety briefings, monitoring safety equipment, and taking immediate action in case of safety violations or emergencies.
• To raise online deviation/CAPA and change control whenever required.
• To prepare and review manufacturing department related documents as per requirement.
• To prepare Process Qualification documents (PQ) of all product stage wise after completion of process validation/re-validation batch.
• Ensuring that the API plant complies with all relevant regulatory requirements and participating in audits and inspections as necessary.
• ERP related all activity carried out (Like BOM, Routing, Stock of Raw material, Intermediates, finished product every batch) as per requirement.
• Prepare every month product stock statement and WIP report given to Finance department.
• To prepare area monitoring and equipment qualification & requalification protocol/report and submit to QA after execution of activity.
• Responsible to take care and closely monitor all Pharma block level-II, III and Intermediate section Level-I related activity as per cGMP requirement.
• Responsible for handling of all consumable items' requirement and availability.
• Responsible for preparation/review all required documents for manufacturing department.
• Responsible for implement the E-log and SAP in Manufacturing department.

Essential Functions

• Manage and coordinate manufacturing documentation activities including batch records, SOPs, and production-related documents in compliance with GMP standards
• Oversee the documentation lifecycle from creation through review, approval, and archival to ensure accuracy, completeness, and regulatory compliance
• Review and approve batch production records to verify that all manufacturing activities have been conducted in accordance with approved procedures and specifications
• Develop and implement documentation workflows and schedules to ensure effective management of manufacturing records across production areas
• Identify documentation gaps, errors, and deviations and initiate corrective and preventive actions to address them in a timely manner
• Ensure all manufacturing documentation complies with applicable regulatory requirements including FDA, EMA, and other relevant authorities
• Train and guide manufacturing personnel on GMP documentation requirements and best practices
• Coordinate with quality assurance and manufacturing teams to ensure seamless documentation support for production activities
• Lead team participation in process improvement projects to develop methods and procedures that enhance documentation quality and reduce errors

Education

• Bachelors Degree (BA/BS) B. Sc. - Required
• Master Degree (MS/MA) M. Sc. - Preferred

Experience

• 8 years or more in 8 - 10 Years