Production Lead

Lupin; Florida; On-site; USD 60,000 - 85,000; Full time

Job summary

Lupin in Florida seeks a documentation specialist to manage and prepare GMP shop floor documents, SOPs, URS, protocols, and batch records. The role requires strong reading and writing of English technical documents and familiarity with GMP processes.

Candidates should have at least a high school diploma with 5+ years in a production cGMP environment and knowledge of FDA guidelines. The work includes maintaining safety standards and collaborating with cross-functional teams at Lupin.

Qualifications

• Proficiency in preparing SOPs, batch records, and related documents.
• Experience with cGMP documentation practices and regulatory guidelines.
• Ability to read and interpret safety rules and batch documentation in English.

Responsibilities

• Handle all types of shop floor documentation including batch documents and logbooks.
• Prepare SOPs, URS, change controls, protocols and qualification documents.
• Ensure timely completion and accuracy of GMP documentation and calibration records.

Skills

Documentation prep

SOP writing

Batch records

cGMP knowledge

FDA knowledge

Education

High school diploma

Bachelor’s degree preferred

Tools

SAP

QMS

Job description

• 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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