Syngene International – Urgent job openings for Production/ QA/ QC/ Discovery Chemistry

Syngene International - Urgent job openings for Production/ QA/ QC/ Discovery Chemistry

Greetings from Syngene International ..!!!
We are hiring following positions for Various Locations.

Click below Post Title for full job details

  1. Senior Executive – Quality Control – Biologics
  2. Research Associate/Senior Research Associate – Discovery Chemistry
  3. Associate Scientist – Discovery Chemistry
  4. Senior Executive – Production
  5. Senior Executive – Quality Assurance
  6. Senior Executive/ Junior Manager – Corporate Quality Assurance


Senior Executive – Quality Control – Biologics

Designation: Senior Executive
Job Location: Bangalore
Department: Quality Control – Biologics
Educational Qualification: Masters in Science (Biochemistry/ biotechnology).
Experience: 3 -6 years
Job Purpose:
This role involves in planning and execution of Bioassay and binding ELISA analysis for Biologics of drug substances/ finished product.
Job Description
Key Responsibilities:

  • Responsible for preparation of documents such as SOPs, IOPs, EOPs etc.
  • Preparation of batch release documents like specifications, STPs with observation data sheet, verification protocols, method transfer protocols etc.
  • Responsible to perform the method transfer analysis and verification activity with documentation for the samples of in-process/finished product.
  • Responsible for uploading and assigning SOP / EOP / IOP in LMS.
  • Responsible to involve and participate during the preparation and general laboratory readiness for the internal / external / client audits.
  • Responsible to complete all planned quality & compliance training as and when required by the department / section or asked by the HOD / Section Head.
  • To prepare the complete list of materials (CLM) required for various project.
  • Responsible to initiate and inform immediately to department HOD/designee, if there are any laboratory incidents, deviations, change controls and out of specification results were observed.
  • Responsible to conduct any job assigned by the superior.
  • Responsible for the training coordinator activity which includes providing of training questionnaire, submitting the GTR to archival QA, preparation of JD, training matrix, training binder, review of training files and assigning training in LMS.
  • Perform sample management duties which may include movement and storage of samples, reconciliation of sample receipt and aliquoting of samples.
  • Responsible for the preparation of stability study related documents like, stability study protocols, observation data sheet, analysis report, stability summary and trend sheets. Responsible for the execution of stability samples charging for stability study. Assistance in setup of bioassay lab as per the direction of Supervisor/ Section Head.
  • Preparation of batch release documents like specifications, STPs with observation data sheet, verification protocols, method transfer protocols etc.
  • Follow environment, health, and safety (EHS) requirements at all times in the workplace ensuring individual and lab/plant safety.
  • Attend training on environment, health, and safety (EHS) measures imparted company.

Technical/functional Skills:

  • Knowledge on Bioassay and Binding ELISA analysis for Biologics substances/ finished product.
  • Experience on method transfer analysis and verification activity with documentation for the samples of in-process/ finished product.
  • Ample knowledge on LIMS.

Behavioral Skills:

  • Strong commitment towards work, and a high level of dedication, enthusiasm, motivation, and persuasive ability in a team.
  • Good speaking-listening-writing skills, attention to details, proactive self-starter.
  • Ability to work successfully in a dynamic, ambiguous environment.
  • Ability to meet tight deadlines and prioritize workloads.
  • Ability to develop new ideas and creative solutions.
  • Should able to work in team and flexible for working in shifts.
  • Should be a focused employee.

Click Here to Apply Online



Research Associate/Senior Research Associate – Discovery Chemistry

Designation: Research Associate / Senior Research Associate
Job Location: Bengaluru
Department: Discovery Chemistry R&D
Educational Qualification: M.Sc (Chemical Sciences)
Experience: 0-6 years
Job Description
Key Responsibilities:

    • Perform synthetic chemistry reactions, reaction work-ups, purification of the compounds by column chromatography, crystallization, re-crystallization techniques, preparative TLC and operating lab equipment
    • Ensure that the samples generated during the course of synthesis are given for analysis and record subsequent results obtained and update the supervisor / group leader on the progress of synthesis and ensure samples are packed appropriately for shipment
    • Record the observations of experiment/reaction, results, utilization of resources and other activities related to the reaction in the laboratory or e-notebook following guidelines and in timely manner and ensure that the same is handled safely and confidentially.
    • Ensure that the instrument / equipments are calibrated, undergone preventive maintenance and are kept clean before use and in case of any breakdown, report to maintenance immediately
    • Ensure that they know the MSDS of the chemicals they are handling and aware of emergency response procedures in case of accidental spillage, leakage or fire and ensure proper waste segregation as per EHS norms
    • Attend all mandatory trainings and update training records as and when trainings are completed
    • Ensure confidentiality at all times
    • Prepare SOPs/IOPs/EOPs/OCPs when any new lab activity is identified or existing one requires updation
    • Any other lab responsibilities as indicated by the EHSQ team member/ supervisor / group leader.
    • Attend training on environment, health, and safety (EHS) measures imparted company
    • Follow environment, health, and safety (EHS) requirements at all times in the workplace ensuring individual and lab/plant safety

    Technical/functional Skills:

    • Should be familiar with concepts of chemical synthesis
    • Familiar with operations of relevant apparatus – instrument / equipment.
    • Good Knowledge of analytical techniques and analytical data interpretation.
    • Good communication skills

    Behavioral Skills:

    • Able to work follow instructions and perform the tasks under the supervision of the project leader
    • Fair interpersonal skills

    Click Here to Apply Online



    Associate Scientist – Discovery Chemistry

    Designation: Associate Scientist / Senior Associate Scientist
    Job Location: Bengaluru
    Department: Discovery Chemistry R&D
    Educational Qualification:
    M.Sc (Chemical Sciences).
    Experience:
    7-12 years relevant experience.
    Job Description
    Key Responsibilities:

    • Perform synthetic chemistry reactions, reaction work-ups, purification of the compounds by column chromatography, crystallization, re-crystallization techniques, preparative (Tables Listings & Columns) TLC and operating lab equipment
    • Assist the supervisor to take stock of resources (raw materials, solvents, etc.) in the project and report any shortfall and search literature using Reaxys
    • Provide hands-on training and supervision to juniors while performing synthesis of compounds
    • Ensure that the samples generated during synthesis are given for analysis and record subsequent results obtained and update the supervisor / group leader on the progress of synthesis and ensure samples are packed appropriately for shipment
    • Record the observations of experiment/reaction, results, utilization of resources and other activities related to the reaction in the laboratory or e-notebook following guidelines and in timely manner and ensure that the same is handled safely and confidentially.
    • Ensure that the instruments / equipment are calibrated, undergone preventive maintenance and are kept clean before use and in case of any breakdown, report to maintenance immediately
    • Ensure that they know the Material Safety Data Sheet (MSDS) of the chemicals they are handling and aware of emergency response procedures in case of accidental spillage, leakage or fire and ensure proper waste segregation as per EHS norms
    • Attend all mandatory trainings and update training records as and when trainings are completed
    • Ensure confidentiality at all times

    • Prepare SOPs/IOPs/EOPs/OCPs when any new lab activity is identified or existing one requires updation
    • Any other lab responsibilities as indicated by the EHSQ team member/ supervisor / group leader.
    • Possess the knowledge and exposure to environment, health, and safety (EHS) practices
    • Follow environment, health, and safety (EHS) requirements at all times in the workplace ensuring individual and lab/plant safety
    • Attend training on environment, health, and safety (EHS) measures imparted company

    Technical/functional Skills:

    • Good knowledge in Synthetic Organic Chemistry and excellent experimental skills (success rate of reaction >80%)
    • Handling of some specialized technical reactions including hazardous/exothermic/sensitive reactions
    • Familiar with operations of relevant apparatus – instrument / equipment.
    • Good Knowledge of analytical techniques and analytical data interpretation.
    • Good communication skills

    Behavioral Skills:

    • Able to work independently and make decisions with minimal supervision
    • Good interpersonal skills
    • Good team player

    Click Here to Apply Online>>



    Senior Executive – Production

    Designation: Senior Executive – Production
    Job Location: Bangalore
    Department: Chemical Development
    Educational Qualification: Master’s degree in chemistry
    Experience: 3-6 years post qualification
    Job purpose:

    • To execute the production activities in API manufacturing unit. Handle of API equipment’s like, Reactor, Centrifuge, Vacuum tray drier and Hydrogentaor

    Responsibilities:

    • Carrying out manufacturing operations in compliance with current Good Manufacturing Practices, Good Documentation Practices and Data Integrity policy.
    • Always ensure readiness of the facility.
    • Monitoring and control of production operations
    • Coordination for Preparation of the master document required for production like SOP, EOP, ECC, BMR and PDR.
    • Checking the readiness of equipment to initiate/execute manufacturing activity, ensure the cleanliness of raw material before bringing inside the plant.
    • Online documentation during batch execution, ensuring documents and annexures are filled.
    • Operate the DCS as per the batch manufacturing record, online update of the operations in the batch manufacturing record by referring DCS.
    • Take care of shift in-charge operations whenever required.
    • Focus on good relationship with all cross functional team.
    • To Operate Reactor, Nutsche filter,Isolators, Dryer, Mill and packing and dispatch of the product.
    • To do online documentation for the activities performed.
    • To handle chemical like Hazardous Acid, Alkali, Reagents and Solvents
    • Documentation capabilities like writing, preparing reports and records for manufacturing
    • Follow environment, health, and safety (EHS) requirements always in the workplace ensuring individual and lab/plant safety
    • Attend training on environment, health, and safety (EHS) measures imparted company

    Technical/Functional Skills:

    • Exposure of handling hazardous chemicals like NBL, DIBAL-H and corrosive reagents.
    • Handling of API equipment’s like, Reactor, Centrifuge, Vacuum tray drier and Hydrogentaor.
    • Having knowledge about handling of regulatory audits and customer audits

    Behavioural Skills:

    • Should have the capability to work in a team and ability to handle demonstrate a good team spirit.
    • While possessing a good ability to follow instruction should also demonstrate innovative in his/her approach, good communication skills.
    • Should be proactive while working on allotted responsibility.

    Click Here to Apply Online>>



    Senior Executive – Quality Assurance

    Designation: Senior Executive
    Job Location: Mangalore
    Department : Quality Assurance
    Educational Qualification: M.Sc Chemistry
    Experience: 3-5 years of experience in API Manufacturing plant
    Job Purpose:

    • Efficiently monitor GMP activities on the shopfloor and ensure compliance to laid down procedures.

    Key Responsibilities:

      • Evaluate and clear the line for Manufacturing, Packing, Quality Control testing as per approved procedures
      • Ensure assurance on execution of manufacturing, packing, quality control testing, and Engineering & Maintenance processes as per laid down procedures
      • Ensure assurance of online documentation of activities
      • Ensure assurance of investigation of root cause and implementation of CAPA in the event of failures / observed non-compliances during internal and external audits
      • Evaluate effectiveness of implemented CAPA.

      Technical/functional Skills:

      • Good working knowledge of ICH Guidelines, Schedule M of Drugs and Cosmetics Act of India, 21 CFR, EU & MHRA GMP regulations
      • Good working knowledge in MS Office (Word, Excel, Powerpoint)
      • Fair Knowledge of statistical tools like Minitab, Statistica
      • Must have good communication skills – Oral and Written
      • Good report writing skills

      Behavioral Skills:

      • Should be highly quality conscious with an urge to protect product quality and patient safety
      • Must have keen sense of observation
      • Good common sense ability
      • Must be a team player and have good interpersonal relationship skills

      Click Here to Apply Online>>



      Senior Executive/ Junior Manager – Corporate Quality Assurance

      Department: Corporate Quality Assurance
      Designation: Senior Executive / Junior Manager
      Educational Qualification:
      M.Pharm / B. Pharm / M.Sc
      Experience: 06-08 years
      Job Location: Bangalore
      Job Purpose:

      • To participate in investigations as Corporate Investigation Team member for GMP- Formulation business (Non-Sterile) unit. (API – Non sterile as a secondary responsible).
      • To ensure adequacy and depth of investigations conducted in Formulation business unit.

      Job Description:
      Key Responsibilities:

      • Responsible to participate/ review the critical investigations, repeated and major investigations (as and when required) pertaining to the Deviations and customer complaints, OOS, OOT etc. in GMP verticals i.e. Formulations & API (Non-Sterile).
      • Responsible to participate and review investigations in GLP, GCP, Discovery, Development verticals as per respective procedures.
      • Ensure the adequacy and depth of investigation within the threshold limit through scoring for all ongoing investigations.
      • Ensure the adequacy and depth of investigation within the threshold limit which ever performed by Business Unit Quality Assurance through Surveillance checks.
      • Responsible to monitor the health of Investigation process and strive for the continuous improvement and play a role of subject matter expert for the site.
      • Perform internal audits as a Subject Matter Expert for BUs, as and when required.
      • Perform GEMBA walk and Safety interaction of the process area and play a role of SQDCE (Safety; Quality; Delivery; Compliance & Engagement) dashboard coordinator.
      • Play a role of Training coordinator for the team.
      • Any other responsibility as assigned by Head Corporate Investigation based on knowledge, experience and training.
      • Follow environment, health, and safety (EHS) requirements at all times in the workplace ensuring individual and lab/plant safety.
      • Attend training on environment, health, and safety (EHS) measures imparted company.

      Technical/functional Skills:

      • Rich technical knowledge on quality assurance and amnufacturing process in GMP Formulation (Non-Sterile) is mandatory. API Non Sterile experience is add on (but not mandatory).
      • Well versed (Experience) with Investigation and Root cause analysis skills is mandatory.
      • Good Technical write up skills; Communication skills and Presentation skills are must.

      Behavioral Skills:

      • Must demonstrate the commitment & dedication towards the work that has been assigned and willing to take new challenges from management based on need.

      Click Here to Apply Online>>

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