Head Of Quality Assurance (Qa) - Fall River

Job Description:
Job Title:Quality Assurance (QA) Manager / Unit Head QA Role Type: Manager/Supervisor Reports To:Head of Quality AssuranceRole Classification: Technical FLSA Status: Exempt
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.
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. In general, the QA work for this manufacturing operation includes: Defining and specifying activities, processes, and standards to fulfill the quality requirements for a manufactured material, component, or product; building and maintaining the infrastructure and systems necessary to consistently ensure the timely delivery of Quality products; auditing, monitoring, and determining the quality of manufacturing processes and/or outputs against defined internal and regulatory standards; and reporting and troubleshooting manufacturing process deviations and defects in finished goods. The QA Unit Head is also responsible for managing and supervising a team of QA professionals at the hourly and salaried levels.
Scope
The scope (content and statements) of this job description is designed to describe the general nature and level of work as well as provide a basic understanding of the role, responsibilities, and expectations of the person assigned to perform the job. This job description is not designed to provide an exact or exhaustive list of all job duties, tasks, skills, and qualifications. The intent of this job description is to be representative of the knowledge, skills, and abilities needed to satisfactorily perform the essential functions of the position satisfactorily and in accordance with the established performance expectations. The scope of the job may be modified with respect to the department, group, and on an individual assigned basis to a sometimes-specific testing group. Consideration of education, relevant training, and experience or a combination of all three may also result in further modification of the role.
1. Organizational Chart
Reports to Role
Direct Reports
Head of QA for InvaGen
QA Specialist
Head of QA for North America
QA Document Control Associate
QA Inspector
QA IT Specialist
QA Training Coordinator
2. Key Accountabilities/Responsibilities
Accountability Cluster
Major Activities / Tasks
I. Plan and review QA activity based on the production plan to enable smoother execution of the unit activities

• Conduct meeting with other stake holders/ QA team member to identify the work priority as per production plan.
• Coordinate with QC team for testing and release of incoming material and finished product.
• Plan and review the validation/ qualification activities for process and equipment as per production plan.
• Evaluate the scope of any improvement in the various sections of Quality Assurance to cater to adequacy of the production plan.
• Ensure the availability of the prerequisites for product transfer and on time submission as per SOP.
• Ensure timely review and response to regulatory communications by monitoring activities of person entrusted with the job.
• Review and approve documents like Gap Analysis, BMR, and FMECA etc. in coordination with Tech Transfer team to adhere to plan set for completion of site transfer/ IPD projects to ensure on time launch.

II. Review and release the batch in order to meet the dispatch plan and to achieve the business goal

• Check availability of reviewed batch documents and approve as per the checklist.
• Approve certificate of analysis received from Quality Control (QC).
• Approve batch release in SAP and batch release certificate.

III. Ensure compliance of internal and external observation are sent timely with proper impact assessment of the observation along with appropriate CAPA to prevent recurrence

• Participate in the discussion with cross functional team on the observation.
• Review and approve the root cause and evaluate the impact assessment.
• Approve the CAPA based on the appropriateness with respect to the observation.
• Ensure that the implemented CAPA is effective to create a robust system if applicable by conducting post implementation reviews as per defined timelines.

IV. Implement robust quality management system at unit level with respect to regulatory requirement for compliance readiness of the unit

• Review and approve proposed modifications made in the facility
• Review and approve deviation, complaints, recall/ return, OOS and OOT based on adequacy of the investigation and root cause analysis.
• Co-ordinate in quality risk management across various functions and department of the organization.

V. Ensure Quality Excellence at unit to achieve continuous improvements

• Monitor the KPl's of Quality metrics on monthly basis to identify the health of the unit.
• Provide action plan on improvement in the KPI which has obtained less score.
• Review and approve the action plan for continuous improvement i.e., SOP, specification, test methods and work systems.
• Conduct Quality Management review for continuous improvement for site head and escalate the findings.
• Verify that the data recorded as a part of process are reliable through document review and verification.

VI. Review and approve documents on time to avoid the close out/ delay for approval of next stage

• Following documents are approved based on their adequacy, appropriateness and correctness as per Good Documentation Practices (GDP): Validation documents, Deviation & CAPA, Change control, complaints, compliance, OOS/ OOT, APQR, SOP, Stability reports, Master batch documents, Other periodic documents and CER.

VII. Assess and review safety and training from a quality perspective to mitigate risks at workplace

• Review safety systems and procedures followed in the unit in coordination with HSE department from quality aspect.
• Evaluate and mitigate potential hazards in unit by tracking all incidents/ accidents and implementing CAPAs.
• Ensure safety training completion in department by coordinating with HSE department.
• Identify training needs of the individuals with respect to cGMP, Safety, Hygiene and principle of Quality functions.
• Provide on the job training (OJT) to individuals and certifications where applicable.

3. Major Challenges/Opportunities

• Maintaining audit readiness.
• Ensuring all quality requirements are met to support the start-up and launch of the MDI lines.
• Leveraging the LOB QA training and compliance program and extending it to the Fall River site.
• Building and developing a site QA team.
• Observing, interpreting, and analysing deviations in quality.
• Reviewing both paper and electronic records.
• Paying strong attention to detail and especially as required to report deviations.
• Managing up and collaborating across geographically dispersed sites and time zones.
• Dealing with ambiguity and changing organizational priorities.
• Ensuring policies, practices and procedures are understood and followed by direct reports, customers and stakeholders.
• Setting goals and objectives for team members for achievement of operational results.
• Supervising professional level employees at the salaried and hourly ranks.
• Prioritizing and balancing both professional and personal commitments.

4. Key Interactions - Roles & Functions
Internal
External

• InvaGen Quality Team
• Cipla Global Quality Team
• Site Leader
• Head of QC - Fall River
• Head of Manufacturing
• Head of Facilities & Maintenance
• Head of EHS
• HR Business Partner
• Third Party Auditors

• Auditors
• Customers
• Regulatory Agencies, e.g., U.S. FDA
• Contract Manufacturers

5. Key Dimensions/Metrics

• Quality Reports and analysis
• Deviations and discrepancies identified.
• Inspections performed.
• Audit Trials reviews.
• Validation deliverables.
• All time readiness - No critical/Official Action Indicated (OAI) in external or internal audits.
• Improvements in major observations in internal audits.
• Corrective action/preventative action (CAPA) closure effectiveness.
• Operating and manpower budgets, and headcount.
• Manpower budget and headcount.
• Workplace and process safety/Total Incident Rate (TIR)

6. Key Decisions
Key Decisions
Key Recommendations
Review data audit trials.
Recommend changes and improvements based on discrepancies found.
Identifying Quality Discrepancy.
Ensure adherence to standards and company SOPs
Documentation of procedures followed.
Compliance with cGMP guidelines
Business growth.
Start-up and validation of Albuterol MDI manufacturing and packing.
Capacity creation.
Installation, qualification, reg batches of new packing line
Commercialization.
Automation of existing MDI Lines
7. Education and Experience, Skills & Competencies
Educational & Experience:

• 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, pharmaceutical manufacturing, and computerized system validation, equipment validation and data integrity.
• Relevant understanding and knowledge about CFR part 11 regulations.
• Basic knowledge about Laboratory Information Management Systems (LIMS) is preferred.

Skills & Competencies:

• QA auditing and effective regulatory communication skills.
• Project management and liaison skills.
• Proficient user of personal computer hardware and software applications such as Microsoft Office tools, and other business applications.
• 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 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.

8. 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.

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.