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Quality Assurance Manager

Company: InvaGen Pharmaceuticals Inc
Location: Providence
Posted on: August 5, 2022

Job Description:

Job Title - Head of Quality AssuranceLocation - Fall River, MASalary - Base salary + Full-time benefitsBonus - 15 % paid AnnuallyBenefits include in this job - 401k Matching(up to 5%) , Medical insurance, Vision insurance, life insurance Dental insurance, Holidays, and other benefitsJob - OnsiteIndustry - Pharmaceutical ManufacturingScope

  • 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. Key Accountabilities/ResponsibilitiesMajor Activities / TasksI. Plan and review QA activity based on the production plan to enable smoother execution of the unit activities
    • Conduct meetings with other stakeholders/ QA team members to identify the work priority as per the 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 the production plan.
    • Evaluate the scope of any improvement in the various sections of quality assurance to cater to the 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 the activities of the person entrusted with the job.
    • Review and approve documents like Gap Analysis, BMR, FMECA, etc. in coordination with the Tech Transfer team to adhere to the 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 is sent timely with proper impact assessment of the observation along with appropriate CAPA to prevent a recurrence
        • Participate in the discussion with the 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 the unit level with respect to regulatory requirements 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 the adequacy of the investigation and root cause analysis.
          • Coordinate quality risk management across various functions and departments of the organization.V.Ensure Quality Excellence at the unit to achieve continuous improvements
            • Monitor the KPI'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 the process are reliable through document review and verification.VI.Review and approve documents on time to avoid the closeout/ delay for approval of the 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 the workplace
                • Review safety systems and procedures followed in the unit in coordination with the HSE department from a quality aspect.
                • Evaluate and mitigate potential hazards in the unit by tracking all incidents/ accidents and implementing CAPAs.
                • Ensure safety training completion in the department by coordinating with the 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.2. 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 analyzing 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 the achievement of operational results.
                  • Supervising professional-level employees at the salaried and hourly ranks.
                  • Prioritizing and balancing both professional and personal commitments.3. Key Interactions - Roles & FunctionsInternalExternal
                    • Company Quality Team
                    • 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 Manufacturers4.Key Dimensions/Metrics
                      • Quality Reports and analysis
                      • Deviations and discrepancies were 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.
                      • Workforce budget and headcount.
                      • Workplace and process safety/Total Incident Rate (TIR)5. 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 Lines6. Education and Experience, Skills & CompetenciesEducational & 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.
                          • Minimum of two (2) years of 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 the 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 by 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.7 - 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.

Keywords: InvaGen Pharmaceuticals Inc, Providence , Quality Assurance Manager, Accounting, Auditing , Providence, Rhode Island

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