Operations Investigator - DPI

NOTICE: The posting for local applicants only - is not for those applying for a global assignment and/or for employees working outside of Cipla's U.S. Subsidiaries or Affiliates.

Job Title


Operations Investigator (Manufacturing and Packaging)


Organization Name


InvaGen Pharmaceuticals, Inc.


Location


Hauppauge, Long Island


Employment Type


Full Time


Hourly Rate

$21 - $30
Benefits


In addition to a fulfilling career and competitive salary, the Company offers a comprehensive benefits package to include a 401(k) savings plan and matching, health insurance - medical/dental/vision, health savings account (HSA), flexible spending account (FSA), paid time off (PTO) - vacation/sick/flex time, paid holidays, short-term disability (STD), long-term disability (LTD), parental leave, paid and unpaid family leave, employee discounts, and other benefits.


Work Hours/ Shift/ Remote


9:00am -5:30pm


OT as required


Responsibilities/ Accountabilities

• Investigation of manufacturing and packaging deviations and non-conformances to determine root cause and implementation of 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.
• Preparing investigation reports that include recommendations on investigation findings for medium/high severity non-conformances and communicating findings and recommendations at group meetings.

• Ability to conduct in-depth interviews and gather pertinent information to drive root cause conclusions, product impact analyses, and initiations of CAPA actions.

• Reviewing completed Batch manufacturing Records (BMR) and logbooks following cGMP standards in support of investigations.
• Reviewing, editing, and revising controlled documents (batch records, logbooks, SOPs, etc.) following cGMP standards to ensure compliance with written procedures.
• Monitoring production processes to acquire vital data in support of investigations and track the efficiency of changes.
• Gathering, trending, and analyzing process-related data to drive consistency and timeliness.
• Training new employees in investigative processes and techniques and documenting all training.
• Coordinating and/or leading cross-functional meetings with multiple departments.
• Prepare product complaint investigations, assist in investigating quality issues, OOS, and OOT, and prepare reports for the same.
• Evaluating, developing, and qualifying manufacturing equipment (IQ, OQ, and PQ) and preparing necessary PQ protocols.
• Risk assessment and risk mitigation by performing 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

Skills/ Competencies

• Proficiency with Microsoft Office, SAP, Track wise.
• Strong analytical skills and proven organizational ability and attention to detail.
• Strong verbal and written communication skills.
• Ability to multitask and work in a fast-paced environment under tight deadlines
• Ability to think analytically, apply sound judgment, and solve problems

• Strong command over written and verbal English is required.
• Interpersonal skills.

• Maintains knowledge of current good manufacturing practices.
• General understanding of equipment, instruments, and systems involved in the manufacturing process.
• Excellent verbal and written communication skills, detail-oriented personality, and ability to work collaboratively across functions
• Experience interacting with regulatory health authorities if needed.
• Knowledge of global regulations and standards.
• Ability to follow gowning procedure and work in a production environment.

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 the expanse of our strong legacy. Over the last five years, Cipla has significantly expanded its portfolio and presence in the U.S. with both a generic and brand division.

InvaGen Pharmaceuticals, Inc.


InvaGen Pharmaceuticals is a Cipla subsidiary engaged in the development, manufacture, marketing, and distribution of generic prescription medicines with focus on a range of therapeutic areas, including 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.


At Cipla, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. 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.