Production Lead

Essential Duties and Responsibilities

• Handle all types of documents at shop floor.
• 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.

Competencies

• Collaboration
• Customer Centricity
• Developing Talent
• Innovation & Creativity
• Process Excellence
• Result Orientation
• Stakeholder Management
• Strategic Agility