Officer Quality Control – 2307001516W
Job Description Summary The 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:
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 testing/ supervision of testing & disposition on materials.
Sampling, testing and review for all RM, PM, Intermediates & Finished products manufactured in Plant.
Maintain lab compliance w.r.t. Data Integrity, Computer System Validation (CSV) and GDP.
Procurement of lab supplies, inventory and services form approved vendors.
Responsible to execute the work done on regional, global and enterprise initiatives in Analytical Laboratory and Ensure Standard and Global Procedures are implemented through JJPS etc.
Responsible to maintain the laboratory ready as a part of Audit Readiness Activities programs for Internal and External Audit Readiness Strategy, Cosmetics rules 2020 compliance and safe working practices as per EHS guidelines.
To ensure operation, upkeep, qualification/validation, calibration & maintenance of analytical instruments like HPLC, FTIR, UV-Vis Spectrophotometer, etc.
Ensure timely closure of Quality control related investigations, CAPA, change controls, GCC OOS/OOT and market complaints.
To coordinate shift operation activities in QC Lab.
Support to Validation/Qualification, maintenance, upkeep & related documentation for Lab Equipment’s (HPLC, FTIR, UV etc.)
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.
Quality System documentation preparation & control (SOP, STM, TM, etc.), preparation ofValidation, Requalification Protocols for laboratoryInstruments/Equipment.
To identify & execute cost improvement and efficiency improvement projects for lab and plant.
To support in Method Validations &Technology Transfer of Analytical/Microbiological methods.
To lead the action plan implementation and action point closure activity timely.
Actively participate in routine testing activities, as needed.
Author and revise 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 another 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 Chemistry/ Microbiology or related science disciplinewith minimum 4 years of experience in Pharma, Healthcare Industry. Knowledge of cGMP’s and related compliance regulations and guidelines is required. CTS in Chemical/ Micro 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.
Primary Location Asia Pacific-India-Maharashtra-Greater Mumbai
Organization JNTL Consumer Health (India) Private Limited
Job Function Quality Control
Req ID: 2307001516W