Job Title: QA Inspector – Compliance

Company:

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. We articulated our 2022 winning aspiration to double the number of patients we serve and hence, double the impact we create as a global pharmaceutical company. Over the last five years, Cipla has significantly expanded its portfolio and presence in the U.S. with both a generic and brand division. We at Cipla are inspired by our purpose of 'Caring for Life' and strive to extend this philosophy to our associates and their families. We are looking for talented individuals to grow their careers while growing our business.

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 Hauppauge, New York. As of February 18, 2016, InvaGen Pharmaceuticals, Inc. operates as a subsidiary of Cipla (EU) Limited.

Location: Fall River, MA

Job Purpose:

The purpose of the QA Compliance Inspector - Compliance position is to monitor and ensure quality systems are maintained throughout all phases of the manufacturing process in compliance with established specifications and standard operating procedures (SOPs).

Duties and Responsibilities:

The Quality Assurance (QA) Compliance Inspector position is an individual contributor role and a member of the InvaGen Pharmaceuticals Quality Team. The position reports to the Site Quality Lead. The essential and typically expected job duties for this position include but are not limited to the following:

• Assemble training documents for new hires
• Maintain SOP binders to be readily available
• Ensure all training files are up to date and filed accordingly
• Assemble quality data to support management review meeting requirements
• Issuing, reviewing, maintaining, and archiving of logbooks
• Creation, review and approval of Change control, deviations, CAPAs
• Training and execution of internal audits, as required
• Review/approval of calibration records for manufacturing equipment
• Identify and report any non-conformances and/or discrepancies to management if applicable.
• Maintain daily inspection readiness of quality systems
• Complete other duties or participate in project work as assigned by management.

Education and Experience:

• Minimum high school diploma.
• Advanced training or education in pharmaceutical quality compliance or related field of study from an accredited college/university.is preferred.
• Minimum of three (3) years’ experience in a quality assurance in a GMP pharmaceutical work environment.
• Experience in MDI, preferred.
• Proficient user of personal computer hardware and software applications such as Microsoft Office tools, SAP, TrackWise and other business applications.

Physical requirements

• Sitting at a desk and/or working at a computer or other "screen" 75% or greater of an 8-hour period.

Professional and Behavioral Competencies:

• Must be able to influence decision-making and facilitate completion of work toward the achievement of the business plan and goals.
• Effective interpersonal relationship skills and the ability to work in a team environment.
• Proficiency in the English language to include usage, spelling, grammar, and punctuation.
• Must have current Good Manufacturing Practices (cGMP) knowledge.
• Must have strong attention-to-detail.
• Must be a self-starter and demonstrate initiative with seeking additional training or direction as needed.
• Must have strong organization and communication skills (written, verbal, and presentation).
• Must be detail-oriented with the ability to multitask and prioritize tasks with strict deadlines.
• No employment sponsorship or work visas.

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.