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Career in Quality Assurance as Manager at Johnson & Johnson

 

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Johnson & Johnson is the world’s most comprehensive and broadly based manufacturer of health care products.In India, Johnson & Johnson operates as a single legal entity and consists of the 3 strategic business units: Consumer Products, Pharmaceuticals and Medical Devices which are independently managed and report into their respective Global business segments.

Post : Manager Quality Assurance

Job Description
DUTIES & RESPONSIBILITIES

  • Facilitate the NCR Process at their respective sites.
  • Authorize and perform invalidation of NCRs, as applicable.
  • Perform site/area Nonconformance data analysis.
  • Present data analysis to the CRB as appropriate.
  • Submit data for Management Review.
  • Ensure training of all NCR users.
  • Facilitate the CAPA Process at their respective sites.
  • Originate CAPA’s in the CAPA Application.
  • Facilitate the CAPA Review Board and maintain objective evidence of the review.
  • Assure all Team Leaders, Team Members, Approvers, and CAPA Review Board members are trained.
  • Assure that data analyses from quality sub-systems are documented and retrievable.
  • Analyze CAPA data for the respective sites.
  • Review of test reports and other laboratory reports.
  • Ensure timely completion of batch cards and its review adequately.

 

Technical Skills
* Working knowledge related to NC / CAPA in EtQ.
* High degree of professional/domain knowledge.
* Excellent analyzing / decision making ability.
* Customer (internal and external) driven approach.
* Expert knowledge of the India Drug and Pharmaceutical Regulations (Including Schedule M), GMP’s, ISO Standards and validation methods
* Demonstrated knowledge and application of, Indian Drug and Pharmaceutical
* Regulations and MDD, ISO 9001, ISO 13485. ISO 11137, ISO 11138, ISO 11135 international standards.
* Computer skills (MS Office, Visio, MS Project etc.)
* Effective communication skills.
* Knowledge of applicable laws and regulations.
* Knowledge of manufacturing environment.
* Quality systems, quality control, quality assurance experience, including hands on advanced quality systems compliance.
* Strong technical, planning, and execution capabilities.
* Ability to analyze, balance and prioritize risk.
* Working knowledge of Microsoft Suite applications
* Computer literate
* Working knowledge of Minitab, preferred
* Develop and sustain value-adding relationships with key customers.
* Lead teams to provide Quality input and guidance to customers. Ability to use in- depth knowledge of customer requirements and expectations, as well as relevant industry standards, to recommend changes to and / or validate Quality of products
* Demonstrates ability to leverage understanding of customer management techniques  for  developing  strong customer relationships
* Demonstrates deep end-to-end knowledge of closely related functional units and Interface between quality and other functions. Demonstrates ability to educate Quality organization on key interdependencies. Influencing business unit leaders in  critical Quality and compliance areas.
* Demonstrates ability to maintain strong relationships with leaders across production, planning & warehouse, engineering and supply chain functions
* Utilize understanding of the typical Quality and compliance challenges faced to Identify unusual circumstances and assess compliance at these phases and Apply appropriately J&J and applicable Health Authority standards requirements to ensure compliance of the product.
* Demonstrates deep knowledge and appropriate use of all key Quality and compliance  Processes and make recommendations for refinement of processes to achieve regional/global standardization.
* Ability to determine necessary adjustments to Quality and compliance processes and  lead the process and associated communications required to update Quality and  compliance process and  Demonstrates ability to appropriately evaluate and interpret process inputs and outputs. Demonstrates ability to explain and/or train others and Ensure all systems are maintained in a compliant state of control.
* Ability to develop, validate, and implement metrics and J&J Quality Standards for various functions and for the Quality and compliance organization and Demonstrates ability to develop and implement processes for monitoring and reporting metrics and Leverages  understanding of  KPI usage to develop achievable improvement goals.
* Demonstrates ability to assess and approve Quality and compliance issues and bring appropriate issues to the board, prepare and present applicable data and issues in a clear and concise manner and Demonstrates ability to lead the meeting when called upon and Identify appropriate resources and materials and provide to executive management board for review.
* Coach others on proper etiquette and procedures for leading investigations.
* Understand investigation results and oversee implementation of corrective actions and solutions.
* Demonstrates ability to identify corrective actions that should be applied internally to other areas of the business / sectors, and escalates them appropriately for use.
* Demonstrates deep knowledge of GMP/GDP/GAMP rules and applicable international regulations
* Understand how GxP application impacts production quality and consequences of non- compliance.
* Develop appropriate remediation plans and activities to support product compliance.
* Develop appropriate SOPs and procedures in response to new regulations
* Knowledge of Operational Excellence that includes Analytics & Problem Solving, Technology & Data Management, Decision Making, Knowledge Management.
* Knowledge of Quality & Compliance which includes Quality Mindset, Compliance Orientation, Environment Health & Safety.
* Knowledge of Business Fundamentals which includes Financial Management & Budgeting, Project Management, Business Case Development, Business Orientation.
* Knowledge of Business Partnering which includes influencing, Change Management, Time Management, Global Mindset & Management.

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Candidate Profile
Education: Graduate/Post Graduate in Chemistry/Microbiology/Pharmacy.
Experience: Minimum 8-10 years Industry Experience in Quality System Implementation, preferably in medical devices. Minimum of 5 years relevant experience in either regulatory compliance, operations, quality, preferred ASQ CQA Certified, preferred

Additional Information:
Experience:-
8-10 years
Qualification: MSc, B.Pharm, M.Pharm, B.Sc
Location: Himachal Pradesh
Department: Pharma
Job Function: Quality Assurance
Requisition ID: 1700168294W

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