Team Leader, Document Control

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Able to lift 40 lbs. without assistance. Adherence to all Good Manufacturing Practices (GMP) Safety Standards. Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc. allowed. Cold Room/Freezers -22 degrees F/-6 degrees C. No contact lens allowed; prescriptive glasses will be provided. Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.). Will work with hazardous/toxic materials.

Job Description

The incumbent will assist the manager to supervise a team to meet production targets/schedules while always maintaining standards of cGMP, safety, and housekeeping. Along with this, the incumbent will perform various tasks and activities listed below for which they are appropriately trained and are in compliance with the cGMP, company and department SOPs, and the safety regulations.

Responsibilities

• Provide support to the Manufacturing Manager to ensure timely closure of all batch manufacture records.
• Subject matter expert for batch manufacturing closure, training, SAP manufacturing transactions, and track wise.
• Attend and support client meetings and interactions as directed.
• Provide PPI support as required on process improvements and lean manufacturing.
• Support in raising, writing change controls, risk assessments, batch record updates, SOPs/WI, and team briefings.
• Review batch records and support the batch release process.
• Carry out investigations, CAPA creation/closure, and change control management.
• Maintain accurate production records, batch records, and quality control documentation according to cGMP regulations.
• Review and verify data integrity in production documents.
• File and archive production records as per company procedures.
• Coordinate the timely delivery of process aids and packaging components for manufacturing.
• Monitor inventory levels and initiate purchase orders when necessary.
• Manage stock rotations and ensure proper storage conditions for sensitive materials.
• Assist with production scheduling and changeover activities.
• Monitor production processes and report any deviations or issues to relevant personnel.
• Coordinate equipment maintenance and calibration schedules.
• Ensure adherence to all relevant Good Manufacturing Practices (GMP) guidelines.
• Participate in internal audits and quality investigations.
• Maintain compliance documentation and training records.
• Manage project timelines and coordinate cross-functional teams.
• Provide administrative support to the operations team, including scheduling meetings and managing calendars.
• Communicate effectively with various departments within the organization.
• Coordinate training sessions or requirements in manufacturing.

Education

• Minimum Diploma in relevant field.

Experience

• Minimum 5 years of relevant experience in the pharmaceutical industry.

Knowledge, Skills, Abilities

• Good understanding of safe working practices and cGMP.
• Highly motivated to work in the pharmaceutical industry.
• Proficiency in Microsoft Office Suite, including Excel and data analysis tools.
• Ability to work effectively in a fast-paced environment and meet deadlines.