Job Title |
DPI Operations Specialist |
Organization Name |
InvaGen Pharmaceuticals, Inc. |
Location |
Hauppauge, NY location |
Employment Type |
Full Time |
Shift |
General |
Salary Range (Base/ Hourly) |
$72,800 a" $93,600 |
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 a" medical/dental/vision, health savings account (HSA), flexible spending account (FSA), paid time off (PTO) a" vacation/sick/flex time, paid holidays, short-term disability (STD), long-term disability (LTD), parental leave, employee discounts, and other benefits. |
Work Hours/ Shift/ Remote |
General Shift: 08:30 AM a" 05:00 PM (may vary based on business needs) |
Responsibilities/ Accountabilities |
Assist in the coordination of daily manufacturing activities to meet production schedules of projects.
- Monitor manufacturing processes for adherence to cGMP, FDA, and Cipla's quality standards.
- Identify and resolve operational inefficiencies, escalating complex issues when necessary.
- Ensure proper documentation of batch records, logs, and deviations.
- Monitor production schedules to ensure timely execution and minimize delays to support ongoing projects.
- Assist in investigating deviations, non-conformances, and CAPAs (Corrective and Preventive Actions).
- Work closely with Quality Assurance (QA) to ensure adherence to standard operating procedures (SOPs).
- Assist in coordinating materials, equipment, and workforce allocation for optimal resource utilization.
- Identify areas for operational improvements, focusing on reducing waste and enhancing efficiency.
- Assist in implementing new technologies and automation in production workflows.
- Collaborate with Quality, Supply Chain, Project Management, Engineering, and R&D teams to resolve operational bottlenecks
- Support training efforts by ensuring clear communication of standard operating procedures (SOPs)
- Monitor operational metrics such as efficiency, compliance rates, and resource utilization.
- Identify areas for improvement in manufacturing activities and contribute to process enhancements.
- Support initiatives aimed at improving overall productivity through data analysis and performance reviews.
- Develop and maintain strong professional relationships with suppliers/vendors to ensure compliance with quality standards and timely delivery of goods and services.
- Create and manage purchase requisition (PR) using SAP for services, contracts, equipments, consumables, and miscellaneous items, ensuring accuracy & alignment with end-user requirements.
- Maintain clear and effective communication with internal and external stakeholders to address issues, facilitate smooth operations, and ensure alignment with project strategies.
- Follow strict internal protocols and Standard Operating Procedures (SOPs) as well as following current Good Manufacturing Practices (cGMP).
- Participate in safety related programs and or safety teams as needed.
- Enforce and follow safety regulations and ensure that their working area is clean.
- Adhere to CIPLAas Safety, Health, and Environmental policies.
- Other duties assigned as required by Management.
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Education Qualifications |
- Bacheloras degree in pharmaceutical sciences or related fields of study.
- Masteras degree in management sciences), operations management, project management or related field (preferred).
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Experience |
2-4 years of experience in manufacturing, operations, or project management. Preference will be given to candidates with experience in pharmaceutical manufacturing. |
Skills/ Competencies |
- Understanding of cGMP, FDA regulations, and pharmaceutical manufacturing processes.
- Experience with ERP systems (SAP preferred) and manufacturing data analysis tools.
- Strong problem-solving abilities, attention to detail, and ability to work in a fast-paced, regulated environment.
- Excellent communication skills, drive, and sense of urgency
- Excellent computer skills, specifically Microsoft Office Suite.
- Follow strict internal protocols and Standard Operating Procedures (SOPs) as well as following current Good Manufacturing Practices (cGMP), complying with legal regulations, monitoring environment.
- Knowledge of pharmaceutical manufacturing and related documents.
- Knowledge and experience writing, revising, and creating cGMP records and SOPas.
- Experience with quality system compliance.
- Ability to work effectively both independently and as part of a team.
- Capable of handling and participating in compliance and regulatory audits at the local and federal levels.
- Experience in Inhalation products (dry powder inhaler) is a plus.
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Physical Demands |
Physical Demands: While performing duties of this job:
- Stand or walk for extended periods of time.
- Reach with hands and arms.
- Use fingers to handle or feel.
- Ability to lift up to 50bs when required.
- Safety/Personal Protective Equipment (PPE) required for this job.
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About CiplaCipla 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 Indiaas 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 aCaring for Lifea, Ciplaas 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 Ciplaas respiratory business in the United States. Equal Opportunity EmployerRace, 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.
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