QA Change Control & Compliance Coordinator

Job Title:                                  QA Change Control Coordinator

FLSA Classification:               Salary, Exempt - Professional 

Work Location:                        Fall River, MA

Work Hours:                            General: 8:30AM – 5:00PM (may vary based on business needs)

Reports To:                              QA Manager

Purpose:  

The content and statements documented in this job description are designed to describe the general nature and level of work as well as provide a basic understanding of the role, responsibilities, and expectations of the person assigned to perform the job.

Job Summary:            

InvaGen Pharmaceuticals, Inc., is looking for a highly motivated and detail-oriented QA Change Control Coordinator. The QA Change Control Coordinator plays a crucial role in supporting Fall River’s strategic plan by providing mission, goals, and strategic plan by providing regulatory support. The Change Control Coordinator is responsible for managing and coordinating the change control process within the organization, ensuring compliance with regulatory requirements and company policies. This role involves overseeing change requests, facilitating cross-functional collaboration, and driving efficient change implementation.

Essential Duties and Responsibilities

• Identify the need of change control in different areas.
• Manage the end-to-end change control process, including initiation, review, approval, implementation, and closure of change requests.
• Develop and maintain standard operating procedures (SOPs) and templates for change control activities.
• Coordinate change control meetings, including agenda preparation, attendee management, and documentation.
• Assess the impact of proposed changes on product quality, safety, and regulatory compliance.
• Collaborate with cross-functional teams (e.g., R&D, manufacturing, quality assurance, regulatory affairs) to ensure timely and efficient change implementation.
• Maintain accurate and up-to-date records of all change control activities.
• Prepare and analyze change control metrics to identify trends and improvement opportunities.
• Provide training and guidance to employees on change control procedures and documentation.
• Stay updated on regulatory requirements and industry best practices for change control.
• Support internal and external audits related to change control.
• Co-ordinate with CFT for closure of change control.
• Send notification to customers related to change control.
• Any other work assigned by Section Head or Head Unit Quality Assurance.

Qualifications

• Bachelor’s Degree in a relevant scientific field (biology, biochemistry etc.).
• Equivalent work experience may be substituted for education.
• Excellent written and verbal communications skills – ability and confidence to collaborate with all levels of the organization. 
• Ability to be organized, flexible and multi-task in a fast-paced environment.
• Must be able to work with all levels of an organization and manage effectively.
• Solid understanding of QA functions and requirements.
• Ability to deal with and handle confidential and sensitive information with discretion and tact.
• Can prioritize effectively and have exceptional organization skills required for our constantly evolving environment. 
• Has strong interpersonal and collaboration skills crucial for team-based working. 
• Extreme attention to detail; ability to draft error-free documents in MS Word and maintain accurate spreadsheets in MS Excel.
• Solid attention to detail in composing and proofreading documents, prioritizing, and achieving desired outcomes promptly.
• Excellent time management skills with a proven ability to meet deadlines.
• Experience with Microsoft 365 (e.g., PowerPoint, Excel, and Word).
• Ability to follow instructions and meet deadlines.

Physical requirements

• Must be willing to work in a pharmaceutical manufacturing setting.
• Must be willing to work some weekends based on business needs as required by management.
• Prolonged periods of sitting at a desk and working on a computer.

GLOBAL COMPANY

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.

Cipla employs handpicked professionals not just for their knowledge and experience but for their zeal to make a difference to the world of healthcare.  The company believes that our biggest assets are the employees who lead us to prosperity and growth in the future.  Driven by the vision, none shall be denied, Cipla’s focus has always been on making affordable, world-class medicines with a reputation for uncompromising quality standards across the world.

CIPLA NEW YORK (INVAGEN PHARMACEUTICALS, INC.)

About InvaGen Pharmaceuticals, a Cipla subsidiary InvaGen Pharmaceuticals, Inc. is 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. As of February 18, 2016, InvaGen Pharmaceuticals, Inc. operates as a subsidiary of Cipla (EU) Limited.

EEO Statement: 

Cipla is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, age, sex, sexual orientation, gender identity, religion, national origin, genetic information, disability, or protected veteran status.