Cipla
Overview
Job Title: Operations Investigator (Manufacturing and Packaging) at InvaGen Pharmaceuticals, Inc. Location: Central Islip and Hauppage, New York. Employment Type: Full Time. Hours: 9:00am - 5:30pm; OT as required. Responsibilities/Accountabilities
Investigation of manufacturing and packaging deviations and non-conformances to determine root cause and implement Corrective and Preventative Actions (CAPAs) to prevent recurrence. Work with cross-functional teams to gather data, lead, and perform Root Cause Analysis to determine the likely root cause of the event. Prepare investigation reports with recommendations on findings for medium/high severity non-conformances and communicate findings and recommendations at group meetings. Conduct in-depth interviews and gather pertinent information to drive root cause conclusions, product impact analyses, and initiations of CAPA actions. Review completed Batch Manufacturing Records (BMR) and logbooks following cGMP standards in support of investigations. Review, edit, and revise controlled documents (batch records, logbooks, SOPs, etc.) following cGMP standards to ensure compliance with written procedures. Monitor production processes to acquire vital data in support of investigations and track the efficiency of changes. Gather, trend, and analyze process-related data to drive consistency and timeliness. Train new employees in investigative processes and techniques and document all training. Coordinate and/or lead cross-functional meetings with multiple departments. Prepare product complaint investigations, assist in investigating quality issues, OOS, and OOT, and prepare reports for the same. Evaluate, develop, and qualify manufacturing equipment (IQ, OQ, and PQ) and prepare necessary PQ protocols. Perform risk assessment and risk mitigation by conducting FMECA (Failure Modes, Effects, and Criticality Analysis). Education Qualifications
A bachelor's or advanced degree in pharmaceutical sciences, chemistry, or a related field is typically required. Experience
2-5+ years’ experience. Proficiency with Microsoft Office, SAP, TrackWise. Strong analytical, organizational, and attention to detail skills. Strong verbal and written communication skills. Ability to multitask and work in a fast-paced environment under tight deadlines. Analytical thinking, sound judgment, and problem-solving abilities. Strong command of written and spoken English; interpersonal skills. Knowledge of current good manufacturing practices. General understanding of equipment, instruments, and systems involved in the manufacturing process. Ability to follow gowning procedures and work in a production environment. Experience interacting with regulatory health authorities if needed; knowledge of global regulations and standards. About Cipla
Cipla is a leading global pharmaceutical company, dedicated to high-quality, branded, and generic medicines. We are trusted by healthcare professionals and patients across geographies. Over the last eight decades, we have strengthened our leadership in India’s pharmaceutical industry and fortified our promise of strengthening our global focus by consolidating and deepening our presence in the key markets of India, South Africa, the U.S., and other economies of the emerging world. Driven by the purpose “Caring for Life”, Cipla’s focus has always been on making affordable, world-class medicines with a reputation for uncompromising quality standards across the world. In the last 85+ years, Cipla has emerged as one of the most respected pharmaceutical names in India as well as across more than 100 countries. Cipla is a fast-growing pharmaceutical company with a continued focus on expanding our strong legacy, including growth in the U.S. market. InvaGen Pharmaceuticals, Inc.
InvaGen Pharmaceuticals is a Cipla subsidiary engaged in the development, manufacture, marketing, and distribution of generic prescription medicines, with focus on cardiovascular, anti-infective, CNS, anti-inflammatory, anti-diabetic, and anti-depressants. The company was founded in 2003 and is based in Central Islip and Hauppauge, New York. In October 2020, InvaGen established its project site in Fall River, Massachusetts to support the launch of Cipla’s respiratory business in the United States. Equal Opportunity Employer
Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status. If you require reasonable accommodation to make your application or interview experience a great one, please contact the recruiter. About the Salary/Pay Range: The salary range mentioned above is an anticipated base salary range for this position. Exact salary depends on several factors such as experience, skills, education, and budget. Salary range may vary based on geographic location. In addition to base salary, this position may be eligible for benefits and participation in a bonus program based on performance and company results.
#J-18808-Ljbffr
Job Title: Operations Investigator (Manufacturing and Packaging) at InvaGen Pharmaceuticals, Inc. Location: Central Islip and Hauppage, New York. Employment Type: Full Time. Hours: 9:00am - 5:30pm; OT as required. Responsibilities/Accountabilities
Investigation of manufacturing and packaging deviations and non-conformances to determine root cause and implement Corrective and Preventative Actions (CAPAs) to prevent recurrence. Work with cross-functional teams to gather data, lead, and perform Root Cause Analysis to determine the likely root cause of the event. Prepare investigation reports with recommendations on findings for medium/high severity non-conformances and communicate findings and recommendations at group meetings. Conduct in-depth interviews and gather pertinent information to drive root cause conclusions, product impact analyses, and initiations of CAPA actions. Review completed Batch Manufacturing Records (BMR) and logbooks following cGMP standards in support of investigations. Review, edit, and revise controlled documents (batch records, logbooks, SOPs, etc.) following cGMP standards to ensure compliance with written procedures. Monitor production processes to acquire vital data in support of investigations and track the efficiency of changes. Gather, trend, and analyze process-related data to drive consistency and timeliness. Train new employees in investigative processes and techniques and document all training. Coordinate and/or lead cross-functional meetings with multiple departments. Prepare product complaint investigations, assist in investigating quality issues, OOS, and OOT, and prepare reports for the same. Evaluate, develop, and qualify manufacturing equipment (IQ, OQ, and PQ) and prepare necessary PQ protocols. Perform risk assessment and risk mitigation by conducting FMECA (Failure Modes, Effects, and Criticality Analysis). Education Qualifications
A bachelor's or advanced degree in pharmaceutical sciences, chemistry, or a related field is typically required. Experience
2-5+ years’ experience. Proficiency with Microsoft Office, SAP, TrackWise. Strong analytical, organizational, and attention to detail skills. Strong verbal and written communication skills. Ability to multitask and work in a fast-paced environment under tight deadlines. Analytical thinking, sound judgment, and problem-solving abilities. Strong command of written and spoken English; interpersonal skills. Knowledge of current good manufacturing practices. General understanding of equipment, instruments, and systems involved in the manufacturing process. Ability to follow gowning procedures and work in a production environment. Experience interacting with regulatory health authorities if needed; knowledge of global regulations and standards. About Cipla
Cipla is a leading global pharmaceutical company, dedicated to high-quality, branded, and generic medicines. We are trusted by healthcare professionals and patients across geographies. Over the last eight decades, we have strengthened our leadership in India’s pharmaceutical industry and fortified our promise of strengthening our global focus by consolidating and deepening our presence in the key markets of India, South Africa, the U.S., and other economies of the emerging world. Driven by the purpose “Caring for Life”, Cipla’s focus has always been on making affordable, world-class medicines with a reputation for uncompromising quality standards across the world. In the last 85+ years, Cipla has emerged as one of the most respected pharmaceutical names in India as well as across more than 100 countries. Cipla is a fast-growing pharmaceutical company with a continued focus on expanding our strong legacy, including growth in the U.S. market. InvaGen Pharmaceuticals, Inc.
InvaGen Pharmaceuticals is a Cipla subsidiary engaged in the development, manufacture, marketing, and distribution of generic prescription medicines, with focus on cardiovascular, anti-infective, CNS, anti-inflammatory, anti-diabetic, and anti-depressants. The company was founded in 2003 and is based in Central Islip and Hauppauge, New York. In October 2020, InvaGen established its project site in Fall River, Massachusetts to support the launch of Cipla’s respiratory business in the United States. Equal Opportunity Employer
Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status. If you require reasonable accommodation to make your application or interview experience a great one, please contact the recruiter. About the Salary/Pay Range: The salary range mentioned above is an anticipated base salary range for this position. Exact salary depends on several factors such as experience, skills, education, and budget. Salary range may vary based on geographic location. In addition to base salary, this position may be eligible for benefits and participation in a bonus program based on performance and company results.
#J-18808-Ljbffr