Our Consumer Business touches a billion lives around the world and works with the vision of ‘Bringing science to the art of healthy living’. In India, the company touches the lives of consumers through businesses spanning baby care, women’s health, beauty, oral & wound care, and over-the-counter-products which are endorsed by healthcare professionals around the world. In India, the company touches the lives of consumers through Baby Care, Women’s Health, Beauty, Oral & Wound Care, and OTC. Some of our key brands include Johnson’s® Baby, Stayfree®, Clean & Clear™, Band-Aid®, Listerine®, ORSL, and Benadryl®.
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.
Position: Executive, R&D Q&C
Location: Greater Mumbai, Maharashtra, India
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
Desired Knowledge & Skills:
- 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.
Qualification: B.Pharma, M.Sc & Above
Experience: Minimum 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)
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