Associate

Job Overview

This role involves adherence to current Good Manufacturing Practices (cGMP), GxP, and other regulatory standards including Environmental Health & Safety. The individual will undertake various production and operational tasks following Standard Operating Procedures (SOPs), ensuring quality, productivity, and compliance.

Key Responsibilities

• Follow all regulatory guidelines and complete necessary training on SOPs before task execution.
• Carry out assigned activities strictly as per SOPs and report any deviations or difficulties immediately.
• Identify and communicate quality issues or suggestions to supervisors and management.
• Perform packing and documentation tasks in accordance with Batch Packaging Records (BPR) and cGMP standards.
• Handle bulk materials, packing materials, semi-finished, and finished products, ensuring proper movement as per SOPs.
• Maintain overall equipment efficiency and productivity while ensuring cleanliness as per GMP requirements.
• Operate, wash, and clean production equipment and accessories following SOPs.
• Monitor and record environmental parameters such as differential pressure, temperature, and humidity as mandated.
• Ensure calibration and scheduled preventive maintenance of equipment and instruments meet required standards.
• Conduct in-process checks and document results within BPRs.
• Manage receipt, issuance, retrieval, and disposal of change parts properly.
• Document area and equipment usage per SOP.
• Participate in all required cGMP, on-job, and functional training sessions.
• Maintain personal hygiene and comply with HR regulations before entering production zones.
• Initiate and review material requisitions, returns, and packing material carry forward requests.
• Exercise effective control over manpower, machinery, and materials to maintain inventory accuracy and operational efficiency.
• Support Quality Management systems by reporting discrepancies, abnormalities, non-conformances, or incidents to department heads.
• Utilize software tools such as Omnidoc and Data Acquisition Systems (DAS) in daily operations.
• Verify packing material proofs against batch records and retain necessary documentation for the packing section.
• Participate in machine troubleshooting and software issues including blister inspection systems and inkjet coding.
• Undertake any additional duties assigned by the department head.

Qualifications and Experience

• Diploma in Pharmacy or Graduation in Science.
• 2 to 5 years of relevant experience in pharmaceutical production or operations.

Competencies

• Strategic Agility
• Process Excellence
• Innovation and Creativity
• Talent Development
• Customer Centricity
• Collaboration
• Result Orientation
• Stakeholder Management