Quality Control SME

2 weeks ago

Billerica, United States Sun Pharma (Taro Pharma) Full time
Job Description

Job Summary

The Quality Control SME role is a dual function role.  The role is divided between QC compliance activities and QC laboratory GMP testing activities.  On the QC compliance side, the SME will ensure compliance is maintained with cGMP, GLPs, and company policies and procedures.  These activities, with management directive will include TrackWise (TW) records, Global Site Actions, evaluating and implementing Global Quality Systems (GQS) documentation and site SOPs, assist with regulatory audit responses, assist with validation programs.  On the laboratory testing side, the SME will also be responsible for GMP testing of raw materials, in-process and finished products, stability sample testing, and non-routine sample analyses per established procedures and methodology, internal laboratory audits, maintaining cGMP/GLP compliance (audit readiness) within the QC chemistry laboratories.

 

Area Of Responsibility

    • Assist and ensure compliance is maintained with cGMP, GLPs, and company policies and procedures within all QC laboratories.  Carry out implementation of robust QC systems to ensure evaluation and improvement of QC processes.
    • Write, coordinate/support, review, and report all TrackWise records including Deviations, Out of Specification (OOS), Out of Trend (OOT), and atypical result investigations where required, CAPS’s, and Change Controls.  Own, Investigate, and document OOS test results and deviations, and investigations for cGMP Quality Control.
    • Work with Quality Assurance to close TrackWise records in a timely manner
    • Assist with Global Site Actions (TW) and evaluating and implementing Global Quality Standard (GQS) documentation and site SOPs. 
    • Support audits to demonstrate compliance of quality control systems.  Assist with regulatory audit responses. 
    • Assist with performing internal lab audits
    • Assist with validation programs (Empower reports, spreadsheets, lab software validations, etc.)
    • Possess the ability to perform statistical analysis and trending of data
    • Expertly carry out hands-on QC laboratory testing activities.  Execute analytical quality control release, stability and complaint (follow-up) testing for raw materials, in-process and final products to ensure compliance with cGMPs, GLPs, GDPs, Quality Assurance Procedures, SOPs and established deadlines
    • Ensure safe operations in the laboratory
    • Support Qualification processes of QC instrumentation/equipment by developing, authoring, and executing instrument IQ/OQ and PQ protocols as needed.
    • Maintain laboratory programs to process, monitor, and evaluate the status of test (release, complaint, or investigation) samples in the Quality Control Laboratory to ensure efficient laboratory throughput and to help maintain monthly metrics
    • Provide mentoring and training to analysts on compliance events such as Trackwise records including deviations, OOS, investigations, and CAPA.
    • QC GMP  testing using Spectrophotometers (UV/Vis), Balances, infrared (IR), gamma radiation and RCP assays, Flame atomic absorption (AA), polarography, high pressure liquid chromatography (HPLC), total organic carbon analyzer, conductivity meter, pH meter, Autotitrator, Karl Fischer moisture analyzers, high temperature furnaces and oven, fume hoods, stirrer/hot plates, compressed gas regulators and cylinders, melting Point, Osmometer, Gas Chromatography (GC), Particle size analyzer
    • Perform monthly equipment/instrument maintenance and cleaning
    • Follow work-flow procedures from receiving test samples, monitoring inventories, to waste disposal
    • Train towards Visual Inspection qualifications
    • Other duties as assigned

     

 

Work Conditions:

  • Office
  • Lab
  • Controlled area/clean room
  • Exposure to noise, heat, open flame and radiation in certain areas
  • Exposure to non-hazardous and hazardous chemicals, toxic metals (arsenic, lead, and mercury)
  • Cryogenic gases (LN 2) and radioactive materials
  • Requires access/work in chemical fume hoods
  • Exposure to/use of syringes and needles

 

Physical Requirements:

  • Stand, walk, sit, use hands and  fingers to handle or feel, reach with hands and arms, climb or balance, stoop, kneel, crouch or crawl, hear and talk
  • Close and color vision
  • Must wear personal safety equipment (gloves, lab coat, gowning, safety glasses & respirator)
  • Lift up to 25 lbs.

 

Travel Estimate

Up to 5%

Education and Job Qualification

  • B.S.in chemistry or related scientific major required
  • Computer literacy/proficiency; PC with spreadsheet and or instrument control software
  • Comprehensive knowledge of wet chemical and instrumental analysis methods, including method development and validation
  •  

Experience

  • Position requires a balance between administrative GMP (office) duties and GMP laboratory work
  • Minimum 6-8 years related experience with minimum 4 years related experience as a GMP laboratory analyst preferred with understanding of cGMP, GLPs, and compliance requirements
  • Strong technical knowledge of analytical chemistry including advanced knowledge of Chromatography
  • Experience with completing and maintaining cGMP documentation (electronic and hard copy) for work performed
  • Detailed knowledge of Quality Management Systems (QMS).  Use of Trackwise, Novatek, and Empower software preferred
  • Experience in participating in event Investigations, Root Cause Analysis (RCA), and CAPA
  • Proficient verbal, written, and interpersonal communication skills
  • Excellent mentoring, training, and oversight skills
  • Ability to work with minimal supervision with strong organization skills

 

 

Disclaimer: The preceding job description has been designed to indicate the general nature and level of work performed by employee 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 as assigned to this job.  Nothing herein shall preclude the employer from changing these duties from time to time and assigning comparable duties or other duties commensurate with the experience and background of incumbent(s).

 

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