Coral Springs, FL Production Lead FL 33065

Job description

Essential Duties and Responsibilities 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. #LI-DNI Competencies Collaboration Customer Centricity Developing Talent Innovation & Creativity Process Excellence Result Orientation Stakeholder Management Strategic Agility Nearest Major Market: Fort Lauderdale Nearest Secondary Market: Miami Apply now » Apply Now Start applying with LinkedIn Please wait... Find similar jobs: Lupin-United States Cookie Consent Manager When you visit any website, it may store or retrieve information on your browser, mostly in the form of cookies. Because we respect your right to privacy, you can choose not to allow some types of cookies. However, blocking some types of cookies may impact your experience of the site and the services we are able to offer. Required Cookies These cookies are required to use this website and can't be turned off. Required Cookies Required Cookies Provider Description Enabled SAP as service provider We use the following session cookies, which are all required to enable the website to function: "route" is used for session stickiness "careerSiteCompanyId" is used to send the request to the correct data center "JSESSIONID" is placed on the visitor's device during the session so the server can identify the visitor "Load balancer cookie" (actual cookie name may vary) prevents a visitor from bouncing from one instance to another Cookies from provider SAPasserviceprovider are required and cannot be turned off Advertising Cookies These cookies serve ads that are relevant to your interests. You may freely choose to accept or decline these cookies at any time. Note that certain functionality that these third parties make available may be impacted if you do not accept these cookies. Consent to all Advertising Cookies Advertising Cookies Provider Description Enabled LinkedIn LinkedIn is an employment-oriented social networking service. We use the Apply with LinkedIn feature to allow you to apply for jobs using your LinkedIn profile. Opting out of LinkedIn cookies will disable your ability to use Apply with LinkedIn. Cookie Policy Cookie Table Privacy Policy Terms and Conditions Consent to cookies from provider LinkedIn