Quality Officer

Role & responsibilities

• Performing with competence, upon training, routine testing following laboratory test methods and procedures.
• Developing a competence, upon training, in the use of laboratory instruments and equipment's,
• Performing calibrations and annual maintenance of laboratory- Instrument life cycle management according to current SOPs.
• Working in compliance with current GxP regarding documenting, testing, and maintaining accurate laboratory logbooks and test data. sheets.
• Initiation and participation in laboratory investigations of non-conforming, lab incident laboratory test results.
• Collecting and preparing laboratory records for evaluation following good documentation       

     practices.

• Ensuring personal compliance with all, local and company regulations, policies and procedures for Health, Safety and Environmental compliance.
• Performing other related duties as assigned by the management and immediate supervisor.
• Testing of Finished product, raw material, packing material, stability, validation and In -process samples.
• Support to test method validation and test method life cycle management for chemical test methods.
• Chromatographic analysis.
• Act as an analyst role for Finished good testing, In-process, validation, Raw material and packing material testing as and when required.
• HPLC & GC column usage and maintenance. Support in HPLC, GC and UPLC calibration /validations and test method validations. Support in new analyst qualification.
• Testing of all FG's as per instruction of supervisor and support in timely releases of FG.
• Responsible for timely testing and release of FG, e.g., HPLC, GC, UPLC analyses and all other FG tests.
• Destruction  of  samples.
• Communicating business related issues or opportunities to their immediate Supervisor. Perform work/ activities as assigned by supervisor.
• Operation of Empower, maintain audit trail. Timely submission of reports and audit trails for review.

• Compliance

  & 

  Training

• Observes & promotes all regulatory requirements as defined per applicable regulations, rules & procedures established by the Company, and notified any. violation or deviation to the immediate supervisor or appropriate authority.
• Complies with all training requirements to perform duties of the job.
• Ensure adherence/compliance to Records Management policies and procedures, as applicable.

• Accountability:

• Maintained 5S states of laboratory, GLP & GMP in laboratory.
• Reagent & Volumetric solution preparation and handling
•  Chemical stock inventory and management.
•  Instrument spare & inventory management.
•  Instrument status labeling.
•  Overall physical instrument room and wet chemistry laboratory accountability.
•  Mobile phase labeling.
• Eye washer & safety shower operation and maintenance

1. AUTHORITIES (if applicable)

• Testing of Raw material, Packing Material, In-process. Stability samples, validation- samples and Finished products.
• Review/Approve of In-Process test report, Instrument usage logbook, calibration report
• Handling of laboratory instrument software's and review.
• CDR viewer and Adaptive Author/Project User.
• Compliance wire for Training purpose.
• LIMS analyst
• Empower analyst
• BMR review
• Review and generate Procedures.
• PR Generate in eMarketplace
• Rejection note preparation and labelling on rejected material
• In-process testing execution
• Report preparation and review
• Providing training to associates and new joined.
• Laboratory investigation OOS/OOT/incidence report preparation.
• Holding of non-conforming products