Description

You will manage technical documentation and manufacturing records within a GxP environment.

Responsibilities

• Create and revise batch records, SAP recipes, and Standard Operating Procedures (SOPs) for tablets, capsules, liquids, suspensions, and powders.
• Manage manufacturing documents through multiple revision cycles to ensure accuracy and compliance with cGMP and regulatory requirements.
• Coordinate packaging material selection, including bottles, caps, labels, and blistering materials, and implement palletization systems using CAPE PAK diagrams.
• Draft and execute protocols for packaging line trials, product rework, and new material testing.
• Execute change controls and collaborate with SMEs, QA/QC, Production, and Regulatory departments to capture accurate documentation.
• Calculate theoretical weights from SKU to pallet level and prepare documentation for new product launches.

Required Skills

• 8+ years of experience in technical writing or benchwork specifically for Liquid and/or Oral Solids Manufacturing.
• Strong understanding of Good Manufacturing Practices (GMP) and GxP environments.
• Expertise in writing, outlining, drafting, revising, and reviewing technical documentation.
• Proficiency in Microsoft Word and Excel for record keeping and data management.
• Experience managing Standard Operating Procedures (SOPs) and batch records.
• Ability to coordinate with third parties for packaging activity reviews and approvals.
• Strong editorial, proofreading, and grammatical skills.
• Bachelor's or Master's degree in a scientific discipline.

Key Skills

Education

ANY GRADUATE