AQA Supervisor

Job Title : Analytical Quality Assurance Supervisor

FLSA Classification : Professional, Exempt

Work Location : Fall River, MA

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

Reports To : Quality Assurance Manager

Salary Range : $78,000 - $99,840

Purpose

This position requires a strong analytical chemistry / lab background and experience. The job duties for this position include but are not limited to the following :

Scope

The Quality Assurance (QA) supervisor position is an individual contributor role and reports to the Head Quality Assurance Analytical for InvaGen Pharmaceuticals, Inc., a Cipla subsidiary located at Fall River, MA.

The job duties for this position include but are not limited to the following :

• Confirming and ensuring the compliance of the protocols and reports of method validations / verifications / comparison reports and any other study reports.
• Monitoring and ensuring of current Good Laboratory Practices (cGLP) followed by laboratory personnel during routine operation to ensure adherence to procedure.
• Verifying the standard operating procedures (SOPs) and test procedures.
• Verifying process validation and characterization-related documents.
• Coordinating with the Regulatory Affairs (RA) and Analytical Laboratory Teams to arrange required documents for timely submission as part of new and existing abbreviated new drug applications (ANDAs).
• Maintaining all the incoming documents with proper tracking, recording, storage and archival of the documents.
• Ensuring review, compliance and approval of laboratory raw data which includes audit trials.
• Reviewing and identifying the gaps within the system during routine monitoring and informing the supervisor for necessary improvements in the identified areas.
• Actively participating in laboratory investigations and incidents as well as ensuring the proper compliance.
• Evaluating and confirming the compliance related to raw materials, in process and finished product analytical documents.
• Conducting random internal audits in analytical lab and ensuring the compliance.
• Assessing and implementing of Pharmacopoeia changes whenever any new edition, supplement, amendment, or other changes of any Pharmacopoeia are in effect.
• Performing other departmental and cross-functional projects and assignments given by the manager.

Education and Experience

Technical Knowledge and Computer Systems Skills

Professional and Behavioral Competencies

Work Schedule and Other Position Information

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.