Work Schedule

Standard (Mon-Fri)

Environmental Conditions

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 -22degreesF/-6degrees C, No contact lens allowed; prescriptive glasses will be provided, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Warehouse

The incumbent will assist 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

To 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 record and support batch release process.
Carry out investigations, CAPA creation/closure and change control management.
Maintaining accurate production records, batch records, and quality control documentation according to cGMP regulations. 
Reviewing and verifying data integrity in production documents.
Filing and archiving production records as per company procedures.
Coordinating the timely delivery of process aids and packaging components for manufacturing. 
Monitoring inventory levels and initiating purchase orders when necessary.
Managing stock rotations and ensuring proper storage conditions for sensitive materials.
Assisting with production scheduling and changeover activities.
Monitoring production processes and reporting any deviations or issues to relevant personnel. 
Coordinating equipment maintenance and calibration schedules.
Ensuring adherence to all relevant Good Manufacturing Practices (GMP) guidelines. 
Participating in internal audits and quality investigations. 
Maintaining compliance documentation and training records. 
Managing project timelines and coordinating cross-functional teams. 
Providing administrative support to the operations team, including scheduling meetings and managing calendars. 
Communicating effectively with various departments within the organization
Coordinate training sessions or requirement in manufacturing.

Education

Minimum Diploma in relevant field.

Experience

Minimum 5 years of relevant experiences in pharmaceutical industry.

Knowledge, Skills, Abilities

Good understanding of safe working practices and cGMP.
Highly motivated to work in 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.

Team Leader, Document Control