Job Information
Cipla USA Machine Operator in Fall River, Massachusetts
The Manufacturing Machine Operator performs all functions relating to the production of MDI (Meted doses inhaler) products; consistent with established Current Good Manufacturing Practices (cGMP), customer requirements and in conjunction with all Standard Operating Procedures (SOP). Manufacturing Machine Operators are responsible for the safe and efficient execution of their job duties, while ensuring product compliance to established standards. Essential Duties and Responsibilities Dispensing raw material and primary packing materials as per work order and checking of raw material and primary packing materials. Ensure the proper planning and execution of batches. Performing cleaning and sanitation of production area and machinery as per respective procedures. Daily monitoring of production performance. Perform manufacturing processes and document activities in batch records and logbooks. Machine operation with minimum rejections and maximum outputs while maintaining quality standards within the standard norms. Operating equipment and performing necessary maintenance on machinery. Ensure equipment upkeep in co-ordination with engineering for preventive maintenance and calibration. Maintaining inventory of machine parts, tools and accessories. Collaborate with packaging, maintenance, quality teams for cross functional activities. Ensure status labelling at all stages of manufacturing, filling and cleaning. Identifying and assisting in any corrective actions. Perform, check and ensure calibration/verification of instruments, equipment and weighing balances as per schedule. Perform line clearance checks. Wearing appropriate PPE as stated in the SOP before entering any processing areas. Following procedures to complete tasks in a safe and efficient manner. Performing duties through the proper safe use of equipment, according to Health & Safety procedures and Equipment Manuals. Be able to operate computer systems with ease. Knowledge of pharmaceutical manufacturing and related documents. Basic understanding of deviation, CAPA, change control, FMECA, OOS, OOT and OOAC. Other Responsibilities Maintaining and followed 100% cGMP, GDP and SOP Compliance during complete operation hours. Complying with all company policies and procedures. Reporting all issues that arises to the department head or reporting manager. Performing daily maintenance on equipment and machinery. Completing all documentation in a timely manner, ensuring their integrity, accuracy and completeness. May be required to assist in the training of other employees in the department. Flexible to work extended hours, to achieve manufacturing schedule when needed. Qualifications High school diploma or equivalent is required. Accredited college certificate or university degree is preferred. Minimum one (1) year of manufacturing experience in pharmaceutical industry. MDI experience is highly preferred. Proficient in the English language (Speaking/Reading/Writing) to understand work instructions and document results. Knowledge of fundamental cGMP and regulatory requirements in a pharmaceutical manufacturing environment highly preferred. Basic understanding of mechanical machinery and the operating principles of control systems. Ability to follow both verbal and written instructions. Demonstrated ability to work in both independent and team environments. Good knowledge of Health & Safety procedures, including, OSHA. Strong mathematical and organizational skills.