Production Documentation Lead

Lupin; Florida; Vor Ort; USD 65.000 - 95.000; Vollzeit

Zusammenfassung

Lupin in FL, US is seeking a Production Documentation Specialist to manage shop floor documentation, SOPs, URS, change controls, protocols and deviations in a cGMP environment.

You'll ensure compliance with FDA, cGMP and GDP, maintain batch records, perform QA-ready documentation, and collaborate with cross-functional teams in manufacturing, while working with SAP and QMS systems and adhering to safety policies.

Qualifikationen

• Education and experience in a production cGMP environment.
• Ability to read and interpret safety rules, SOPs and batch records in English.
• Knowledge of FDA, cGMP, GDP and SOPs related to job requirements.

Aufgaben

• Handle all types of shop floor documents and records.
• Prepare SOPs, URS, change controls, protocols and deviation documentation.
• Maintain GMP documentation and ensure accuracy of batch records.
• Fill batch documents, logs, and calibration records; ensure cleanliness and safety.
• Familiar with SAP and QMS documentation systems and training processes.

Kenntnisse

Documentation preparation

SOP writing

URS preparation

GMP knowledge

Batch document handling

English proficiency

Ausbildung

High school diploma

Accredited college certificate or university degree preferred

Tools

SAP system

QMS system

Jobbeschreibung

• To handle all types of documents at shop floor.
• To prepare documents like SOP’s, User requirement specification of equipment’s, change controls, protocols, qualification documents. Deviations etc.
• Good knowledge of pharmaceutical shop floor documentation.
• Can able to handle / fill all type of shop floor documentation like batch document filling, SOP writing, In process, logbook filling, weighing balance verification and calibration records, cleaning and sanitation records, maintenance records.
• Should be familiar with SOP and URS preparation work.
• Should have knowledge of GMP area.
• Should have basic knowledge of GMP equipment’s operation and process flow.
• Should have basic knowledge of batch manufacturing, filling, and packaging operations for MDI and DPI products.

Compliance & Safety

• Adhere to all cGMP, regulatory, and company compliance requirements.
• Follow all Health & Safety policies, procedures, and training guidelines.
• Properly use required Personal Protective Equipment (PPE) at all times.
• Maintain a clean, safe, and organized work environment.
• Complete all required training and maintain qualification status.

Team & Culture

• Work collaboratively as part of a cross-functional team to meet production goals.
• Operate in alignment with the company’s Code of Conduct and Business Ethics.
• Perform additional duties as assigned by Manufacturing Management.

Specialized Knowledge:

• Should have deep understanding of documentation preparation like SOP. Batch documents, URS, protocols etc.
• Should have deep knowledge of quality management system documentation like change controls, deviations, OOS, OOT etc.
• Should have familiar with training process.
• Should have familiar with SAP system, QMS system etc.

Qualification and Experience

Education and Experience

• High school diploma.
• Accredited college certificate or university degree is preferred.
• Minimum of 5 years+ of experience and/or training; or equivalent combination of education and experience within a Production cGMP Environment.
• Knowledge of FDA, cGMP, GDP and SOPs related to job requirements.
• Ability to read and interpret documents in English such as safety rules, Standard Operating Procedures, batch records, and cleaning procedures.
• Proficient in English to sign and complete batch record documentation.
• Ability to speak and understand English effectively.
• Ability to add, subtract, multiply and divide using different units of measure to include averages of whole numbers, common fractions, and decimals.
• Ability to apply common sense thinking and understanding to carry out detailed written instructions.

Physical Requirements

While performing the duties of this job, the employee is regularly required to sit, stand, walk, stoop, kneel, crouch, or crawl for a minimum of 8 hours. Employee will be subject to temperatures ranging from 2°C to 25°C on a daily basis and must be able to transport product in and out of refrigerated cooler within those temperature ranges. Employee must frequently lift and/or move up to 40 pounds. While performing the duties of this job, the employee is regularly exposed to moving mechanical parts. The employee may be exposed to fumes airborne particles, toxic and/or caustic chemicals (PPE Provided). The noise level in the work area may be loud at certain times. The employee will be required at times to wear a full-face respirator and/or TYVEK or TYCHEM jumpsuits during cleaning operations, as well as eye protection, hearing protection, and other personal protective equipment (PPE) as required. The employee may be required to work additional hours from time to time, including weekends (O/T). Shift hours are subject to change due to operational needs.

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