Senior Officer Quality & Compliance

Caring for the world, one person at a time has inspired and united the people of Johnson & Johnson for over 125 years. We embrace research and science - bringing creative ideas, products and services to advance the health and well-being of people. Every day, our more than 130,000 employees across the world are blending heart, science and ingenuity to profoundly change the trajectory of health for humanity.

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®

he QC Analyst conducts quantitative and qualitative analysis of Regulated /Non-Regulated products according to FDA, cGMP and Johnson & Johnson Pvt. Ltd. Standard Operating Procedures. Duties shall include analysis of Cosmetic products through compendial methods and specific test protocols. In addition, the QC Analyst shall be involved in plant interactions/ assessments, system improvements and validation activities (Instrument, Method and Process).

Primary Duties and Responsibilities as Microbiologist

• To ensure implementation of Good Laboratory Practices & Good Documentation Practices in the Quality Control Laboratory.

• On-time & accurate disposition decision for all Materials and Products post testing.

• Responsible for performing, supervision of testing & disposition on materials and products as approved competent Technical Staff (CTS) in Microbiology section from local FDA.

• Sampling, testing and review for all RM, PM, Intermediates & Finished products manufactured in Plant for Microbiological testing

• Responsible for overall functioning of the Microbiology lab, in accordance with GLP as per Internal/External & Regulatory requirements.

• Oversight & Support in all routine activities in microbiology lab such as, Media Preparation, Cleaning and Sanitization, Environmental Monitoring, Water System Monitoring, Routine monitoring of Equipment and Instruments in microbiology lab, Utility samples collection and analysis and routine culture maintenance activity.

• Support to Validation/Qualification, maintenance, upkeep & related documentation for Micro Lab Equipment’s (Autoclaves, Incubators, LAF’s, etc.)

• Support to Validation/Qualification and periodic monitoring of Direct Impact Systems e.g., HVAC System (Environment monitoring), Purified Water System, Compressed Air, Moist Heat Sterilizer and Autoclave etc. and their trending & record maintenance. • Management of lab documents, logbooks, Trends & record retention as per applicable SOPs.

• Maintain Lab compliance w.r.t. Data back-up , Data Integrity, CSV, review of lab logbooks & analytical records.

• Ensuring compliance of the procurement requirements and maintaining adequate inventory of the Chemical, Microbiological Media, and other required items in laboratory. • Quality System documentation preparation & control (SOP, STM, TM, etc.), preparation of Validation, Requalification Protocols for laboratory Instruments/Equipment.

• Ensure timely closure of investigations and NC, CAPA, GCC & OOS/OOT related to laboratory and Plant (Whenever assigned).

• To conduct microbiological investigation & troubleshooting, for cause basis.

• Audit Readiness of lab for internal/external audits as per J&J Quality & EHS standards and Cosmetics rules 2020 compliance.

• Management of Trainings Analyst Qualification as per applicable SOPs. Training to self & all concern. Ensuring proper lab upkeep and 5S.

• To identify & execute cost improvement and efficiency improvement projects for lab and plant.

• To support in Method Validations & technology Transfer of Microbiological methods.

• To lead microbiology risk assessment at site, Plant Hygienist. • To Prepare, execute and ensure compliance of MRA Plan for Plant. To support plant related activities as SME Microbiology and MRA. To participate in MRA assessment of site.

• To lead the action plan implementation and action point closure activity timely.

• To report MRA matrix data on time and represent site in regional forum. Primary Duties and Responsibilities in Chemical Lab (Added Advantage) • Responsible for performing, supervision of testing & disposition on materials and products as approved competent technical staff (CTS) in Chemical section from local FDA.

• To co-ordinate Testing of sample through Public Testing Laboratory (PTL)

• Maintain lab compliance w.r.t. Data Integrity, Computer System Validation (CSV) and GDP.

• Responsible to execute work done on Regional, Global and Enterprise initiatives in Analytical Laboratory and ensure Standard and Global Procedures are implemented.

• Responsible to maintain the laboratory all time Audit Ready for Internal and External Audits.

• To ensure operation, upkeep, qualification, calibration & maintenance of analytical instruments like HPLC, FTIR, UV-Vis Spectrophotometer, etc.

• To coordinate shift operation activities in QC Lab.

• Responsible for training of self and Lab Training Management and to initiate and complete qualification process of Analyst.

• To review Lab Testing data and provide disposition status of Raw Material and Packing Material on time.

• Responsible for review and Maintenance of Volumetric Solutions and Reagents/ indicators used during analysis in Laboratory.

• Ensure Safe working practices followed in lab as per EHS guidelines.

• Lab upkeep and 5S management in lab.

• To conduct and ensure on time sampling & testing for incoming materials, in-process materials/products and finished products being manufactured in the plant.

• Review & revision of applicable SOPs, RM, FP and PM specifications.

• To reviews laboratory cleaning record and destruction of post analysis samples.

• Responsible for verification of periodic reviews of chemicals

Additional Responsibilities

• Actively participate in routine testing activities, as needed.

• Authors and revises procedures under minimal supervision.

• Follow all safety rules and regulations & conducts periodic safety audits.

• Capable to perform work under minimum supervision and will provide oversite to projects and assist other Chemist as needed. To interact with chemists and other personnel regarding testing, procedures performed, related results and prepare reports.

• Works to learn and improve on other techniques and tasks.

• Works under minimum supervision to ensure all work performed is executed in compliance with standard operating procedures, good manufacturing practices, and applicable regulations

Requirements & Qualifications

Master’s Degree in Microbiology, Master’s Degree in Bio-Technology or related science discipline with 5-8 years of related work experience in Pharma , Healthcare Industry. Knowledge of cGMP’s and related compliance regulations and guidelines is required. Microbiology CTS is a must for this position, Chemical CTS is advantage. Minimum Skills Requirements • Must have the ability and skill to perform detailed job requirements noted above competently, safely and proficiently. • A self-starter, motivated person who possesses good interpersonal skills capable of effectively interacting with all departments and client personnel. • Must have excellent organizational, verbal communication, Technical documentation skills , Good Computer skills and well versed in SAP Functionalities . • Knowledge of safe laboratory practices, proper knowledge of handling chemicals and samples. • Must be a team player with high integrity and reliability.

Are you ready to impact the world?

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.

We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, gender, sexual orientation, age, marital status, veteran status, or disability status.

This description has been designed to indicate the general nature and level of work performed by employees within this classification. It is not designed to contain or be interpreted as a comprehensive inventory of all duties, responsibilities, and qualifications required of employees assigned to this job.