Cipla USA
Head of Quality Assurance (QA) - Fall River -
Cipla USA, Fall River, Massachusetts, us, 02720
Job Description:
Job Title:
Quality Assurance (QA) Manager / Unit Head QA
Role Type:
Manager/Supervisor
Reports To:
Head of Quality Assurance
Role Classification:
Technical
FLSA Status:
Exempt
Company:
Cipla
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:
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.
Purpose The purpose of this first-level management/team leader position is to serve as the Head of Quality Assurance (QA) program and associated activities for InvaGen Pharmaceuticals, Inc. Albuterol Metered Dose Inhalation (MDI) line of business located in Fall River, MA (Unit IV). This is a functional leadership role that is responsible for the control and implementation of the QA function within the organization. This role is expected to ensure that the final product is as per the desired safety, quality, identity, integrity, purity and is safe for human use.
Key Accountabilities/Responsibilities
Plan and review QA activity based on the production plan to enable smoother execution of the unit activities.
Review and release the batch in order to meet the dispatch plan and to achieve the business goal.
Ensure compliance of internal and external observation are sent timely with proper impact assessment of the observation along with appropriate CAPA to prevent recurrence.
Implement robust quality management system at unit level with respect to regulatory requirement for compliance readiness of the unit.
Ensure Quality Excellence at unit to achieve continuous improvements.
Review and approve documents on time to avoid the close out/ delay for approval of next stage.
Assess and review safety and training from a quality perspective to mitigate risks at workplace.
Education and Experience, Skills & Competencies
Minimum of a bachelor's degree in Chemistry, Pharmaceutical Sciences, Quality Management or related field of study from an accredited institution.
Minimum of seven (7) years of experience working in a QA Department or QC lab, preferably in a pharmaceutical manufacturing company preferred.
Minimum of two (2) years supervisory and team leadership experience, both hourly and salaried staff.
Working knowledge and direct application of cGMP and regulatory guidelines related to QA.
Relevant understanding and knowledge about CFR part 11 regulations.
Basic knowledge about Laboratory Information Management Systems (LIMS) is preferred.
Physical Requirements:
Work standing or walking unassisted for 75% or greater of an 8-hour period.
Unassisted lifting up-to 10 kg, may be required.
Able to wear appropriate personal protective equipment at all times, when required.
Sitting at a desk and/or working at a computer or other "screen" 75% or greater of an 8-hour period.
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 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 satisfactorily complete pre-employment drug testing.
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Quality Assurance (QA) Manager / Unit Head QA
Role Type:
Manager/Supervisor
Reports To:
Head of Quality Assurance
Role Classification:
Technical
FLSA Status:
Exempt
Company:
Cipla
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:
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.
Purpose The purpose of this first-level management/team leader position is to serve as the Head of Quality Assurance (QA) program and associated activities for InvaGen Pharmaceuticals, Inc. Albuterol Metered Dose Inhalation (MDI) line of business located in Fall River, MA (Unit IV). This is a functional leadership role that is responsible for the control and implementation of the QA function within the organization. This role is expected to ensure that the final product is as per the desired safety, quality, identity, integrity, purity and is safe for human use.
Key Accountabilities/Responsibilities
Plan and review QA activity based on the production plan to enable smoother execution of the unit activities.
Review and release the batch in order to meet the dispatch plan and to achieve the business goal.
Ensure compliance of internal and external observation are sent timely with proper impact assessment of the observation along with appropriate CAPA to prevent recurrence.
Implement robust quality management system at unit level with respect to regulatory requirement for compliance readiness of the unit.
Ensure Quality Excellence at unit to achieve continuous improvements.
Review and approve documents on time to avoid the close out/ delay for approval of next stage.
Assess and review safety and training from a quality perspective to mitigate risks at workplace.
Education and Experience, Skills & Competencies
Minimum of a bachelor's degree in Chemistry, Pharmaceutical Sciences, Quality Management or related field of study from an accredited institution.
Minimum of seven (7) years of experience working in a QA Department or QC lab, preferably in a pharmaceutical manufacturing company preferred.
Minimum of two (2) years supervisory and team leadership experience, both hourly and salaried staff.
Working knowledge and direct application of cGMP and regulatory guidelines related to QA.
Relevant understanding and knowledge about CFR part 11 regulations.
Basic knowledge about Laboratory Information Management Systems (LIMS) is preferred.
Physical Requirements:
Work standing or walking unassisted for 75% or greater of an 8-hour period.
Unassisted lifting up-to 10 kg, may be required.
Able to wear appropriate personal protective equipment at all times, when required.
Sitting at a desk and/or working at a computer or other "screen" 75% or greater of an 8-hour period.
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 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 satisfactorily complete pre-employment drug testing.
#J-18808-Ljbffr