What are the responsibilities and job description for the QA Director position at Cipla USA?
About Cipla
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 Indiaas 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.
Driven by the purpose aCaring for Lifea, Ciplaas focus has always been on making affordable, world-class medicines with a reputation for uncompromising quality standards across the world.
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. Over the last five years, Cipla has significantly expanded its portfolio and presence in the U.S. with both a generic and brand division.
InvaGen Pharmaceuticals, Inc.
InvaGen Pharmaceuticals is a Cipla subsidiary 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. In October 2020, InvaGen established its project site in Fall River, Massachusetts to support the launch of Ciplaas respiratory business in the United States.
Job Title
QA Director
Organization Name
InvaGen Pharmaceuticals
Location
550 South Research Place Central Islip, NY 11722
7 Oser Ave, Hauppauge, NY 11788
Employment Type
Hourly / Full Time)
Full Time a" Salaried / Exempt
Salary Range
Base / Hourly)
165,000 - $190,000
Benefits
In addition to a fulfilling career and competitive salary, the Company offers a comprehensive benefits package to include a 401(k) savings plan and matching, health insurance a" medical / dental / vision, health savings account (HSA), flexible spending account (FSA), paid time off (PTO) a" vacation / sick / flex time, paid holidays, short-term disability (STD), long-term disability (LTD), parental leave, paid and unpaid family leave, employee discounts, and other benefits
Work Hours / Shift / Remote
8 : 30 AM a" 5 : 00 PM
Responsibilities / Accountabilities
The general duties and responsibilities of the "Director QA " include but are not limited to the following :
a Develop, establish and maintain Quality Management System as per 21 CFR Part 11 requirements for products manufactured at Invagen New York facility.
a Accountable to ensure product quality of all manufactured and released products at site.
a Ensure compliance of products manufactured at site.
a Ensure the highest standard of Data integrity is maintained at site.
a Ensure compliance of all quality unit personnel in maintaining a safe work environment.
a Ensure compliance with cGMP as laid down in the procedures.
a Review and or approval of Deviation, change control, CAPA, complaints and Laboratory non-conformance.
a Accountable for Batch disposition based on its testing results.
a Development of talent in the Quality organization.
a Subject matter expert on technical and compliance issues related solid oral drug products and Drug Device combination products.
a Ensure and maintain the facility as per all-time audit readiness mode.
a Conduct management review meetings to apprise Senior management on the effectiveness of QMS for combination products and other Drug products manufactured in the facilities.
a Ensure compliance with all good documentation practices.
a Ensure adequate investigation and timely closure of QMS action items.
a Ensure implementation and effectiveness check of global CAPA at site.
a Ensure Qualification and validation of Equipmentas, Facilities and Process for the sites,
a Support for submission of internal and external audit response on timely manner.
Education Qualifications
a Minimum a bacheloras degree in science / pharmacy or equivalent area of Science.
a Masteras degree in a science related field is preferred.
Experience
- Experience in Operation Quality of Pharmaceutical drug products must include Drug Device combination products.
- Around 10 to 15 years of experience in areas of Operational quality including at least 5-7 years in a leadership role in a Regulated Pharmaceutical Industry environment.
- Should have all required regulatory compliance knowledge and competency for drug product manufacturing, environmental monitoring, area classification requirements.
Skills / Competencies
Physical Requirements
Other Information
No remote work available. Relocation available.
Equal Opportunity Employer
Cipla USA & its U.S. Affiliates are committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to without regard to race, national origin, religion, age, color, sex, sexual orientation, gender identity, disability, or protected veteran status, or any other characteristic protected by local, state, or federal laws, rules, or regulations.
At Cipla, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact careers.northamerica@cipla.com .
Pre-employment Process
Applicants who receive a conditional offer must satisfactory complete pre-employment drug testing.
Disclaimer on Pay Ranges
About the Salary / Pay Range : The salary range mentioned above is an anticipated base salary range for this position. Exact salary depends on several factors such as experience, skills, education, and budget. Salary range may vary based on geographic location. In addition to base salary, this position may be eligible for benefits and participation in a bonus program based on performance and company results.
Salary : $165,000 - $190,000
