PKG. Documentation Specialist II

Job Title : Pkg. Documentation Specialist II

FLSA Classification : Professional, Exempt

Work Location : Fall River, MA

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

Reports To : Department Head - Manufacturing

Salary Range : $72,800 - $93,600

Job Overview

Invagen Pharmaceuticals is searching for experienced candidates for the position of Documentation Specialist.

The Documentation Specialist is responsible for the creation and revision of new and existing GMP batch production records as well as SOP's. In this role the Documentation Specialist adheres to the company's document and SOP's procedures while ensuring their accuracy, quality, and integrity. This position reports to the Department Head - Manufacturing and partners with cross functional team members to ensure compliance and operational success through user focused documentation at InvaGen Pharmaceuticals, Inc, Fall River, MA.

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

• Works with Manufacturing / Packaging to deliver timely batch record review across all shifts.
• Reviews and approval of master batch records.
• Develops appropriate disposition metrics, works with manufacturing / packaging personnel to achieve said targets. Generates and reports on metrics on agreed frequency
• Creates training materials for subject matter input.
• Track and manage periodic review of approved procedures.
• Develop strategies and documents for cleaning and process validation of equipment and products in compliance with site SOPs and regulatory guidance.
• Provides data to support management evaluation of performance trends.
• Owns quality records (change control, CAPA's, deviations) and delivers to established timelines.
• Autonomously leads and manages projects to implement continuous improvement opportunities.
• Lead and / or support root cause investigations related to performance trends and formal deviations.
• Develop, implement and assess solutions for complex problems.
• Anticipates risk and builds contingencies to help mitigate impact.
• Reviews document for accuracy and completeness.
• Defends the validation programs and strategies to customers and regulatory auditors.
• Performs weekly quality reviews of Master Control database by assuring new documents have been entered using appropriate protocols.
• Follows strict internal protocols and Standard Operating Procedures (SOPs) as well as following current Good Manufacturing Practices (cGMP), complying with legal regulations, monitoring the environment.
• Performs other duties as assigned.

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.

Cipla, Inc is an equal opportunity and affirmative action employer committed to building an inclusive and diverse workforce.