J&J Research Executive Vacancy 2020 – Johnson & Johnson
Johnson & Johnson offers an unusual experience to professionals looking for an opportunity to work with hardworking people who share your real passion for caring in an environment that empowers you to drive your own career.
Job Title: Executive, R&D Q&C
Location: Greater Mumbai, India
Qualifications
Education, Experience, Knowledge Skill and Ability Requirements
- At a minimum, B.Pharm or M.Sc. degree
- At least 5 years experience in Analytical and/or Microbiology laboratory, QC or QA functions in regulated Pharmaceutical or Consumer Health company; preferably with experience on managing foreign health authority inspections (US FDA and/or EMA)
- Knowledge of regulatory guidelines like ICH and USFDA
- Thorough understanding of data integrity requirements in Analytical and Microbiology Laboratories
- Experience of working on laboratory systems such as LIMS and Empower
- Analytical thinker and possesses strong problem-solving skills.
- Can easily learn computerized systems
- With strong communication and interpersonal skills.
- Ability to independently plan, organize, coordinate, manage and execute assigned tasks.
- Demonstrate the ability to challenge the status quo.
Role & Responsibilities:
- Supports R&D Q&C Lead in maintaining Quality System within the R&D environment.
Conducts internal audits and GEMBA walks in analytical and microbiology laboratories
Coordinates site inspection readiness activities - Participates in nonconformances, out of specification and out of trend investigations to ensure that the root cause is appropriately identified, and robust CA/PA taken. Reviews and approves investigation and CAPA reports to ensure that documentation is complete and consistent to meet the GDP requirements.Reviews and approves GxP documents
- such as change controls, standard operating procedures, stability protocols and reports, test method validation/transfer protocols and reports, instrument qualification protocols and reports.
- Provides quality and compliance oversight of contract laboratories through periodic reviews of the contract laboratories’ quality system (deviations, CAPA, change controls, investigations)
- Conducts periodic reviews of computerized system validation
- Supports R&D Q&C Lead on supplier management (supplier audits/monitoring and preparation of quality agreements)
- Consolidates/analyzes quality metrics for Quality Data Review and proposes continuous improvements based on the analysis
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