AQA QA Associate II

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 : QA Associate II AQA

FLSA Classification : Professional, Exempt

Work Location : Central Islip, NY

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

Reports To : Quality Assurance Manager

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 Analytical Quality Assurance (AQA) associate II O III position is an team or individual contributor role and reports to the Supervisor Analytical Quality Assurance for InvaGen Pharmaceuticals, Inc., a Cipla subsidiary located at Happauge, NY.

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

• Reviewing and confirming the compliance related to raw materials, inprocess and finished product analytical documents.
• Monitoring and ensuring of current Good Laboratory Practices (cGLP) followed by laboratory personnel during routine operation to ensure adherence to procedure.
• Confirming and ensuring compliance of the protocols and reports of method validations / verifications / comparison reports and any other study reports.
• Prepare and review laboratory investigation (OOS / OOT / Deviation) reports and ensure compliance of same.
• Verifying the laboratory chemicals / reagents, standards for completeness of the labels against standard operating procedures (SOPs).
• Assessing and implementing Pharmacopoeia changes whenever any new edition, supplement, amendment, or other changes of any Pharmacopoeia are in effect.
• Review of laboratory audit trials during data review against standard operating procedures (SOPs).
• Coordinating with the Analytical Laboratory Teams to arrange required documents to cross functional teams.
• Maintaining all the incoming documents with proper tracking, recording, storage and archival of the documents.
• Reviewing and identifying the gaps within the system during routine monitoring and informing the supervisor of necessary improvements in the identified areas.
• Actively participating in review of data related to laboratory investigations and incidents and ensuring proper compliance.
• Performing other departmental and cross-functional projects and assignments given by the manager / supervisor.

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.