Quality Specialist Iii Qa Tapi

Year    Gwalior, Madhya Pradesh, India

Job Description


Who we areTAPI is the leading international supplier of active pharmaceutical ingredients (APIs). With the industry's broadest portfolio including over 350 API products. We are the go-to global supplier for APIs, supporting 80% of top 50 global pharmaceutical companies. We are proud of our reliable history in the generic API industry dating back over 80 years, and the fact we are considered to be one of the most trusted API suppliers, these enable TAPI to lead the industry, based on our experience, expertise, technologies, and exceptional customer service.
Our employees are at the core of our success. Our Headquartered is in Israel, TAPI employs more than 4,000 professionals at 14 sites worldwide. Our state-of-the-art production facilities are located in Italy, Hungary, the Czech Republic, Croatia, Israel, Mexico and India. Our significant ongoing investment in R&D generates a steady flow of APIs, enabling timely introduction of new products to marketHow you'll spend your day

  • Ensure on time dispatch related activity like verification of any deviation/OOS/LIR and other related QMS elements in the batch or its batch train.
  • Ensure Review of all documentation (i.e. batch records, test results, deviation, LIR, OOS, CAPA, validation, COA, Change Controls, etc.) and perform disposition (release/rejection) of batches.
  • Ensure review of executed document like batch record, analytical data etc. and to ensure on time compliance of error/deviations identified (if any).
  • Monitoring and follow-up of corrective and preventive actions (review, approval, and on time closure of the CAPA) in order to resolve an event.
  • Review and approval Process / documentation (i.e. Protocol/report) of reviewing effectiveness to determine the effectiveness of a corrective or preventive action.
  • Involving in investigation, Review, and ensuring on time closure of the investigation with resolution including corrective and preventive actions along with effectiveness determination.
  • Responsible for assuring / coordinating for timely shipment, delivery, and/or receipt to assure compliance with regulatory requirements.
Your experience and qualifications
  • Required B.Sc./ M.Sc. qualified candidate
  • 3 to 4 years relevant experience
  • Hands on experience in batch disposition, Batch card review and Batch Release
  • Basic Knowledge about Deviation / OOS Investigation
  • Audit experience of USFDA / EDQM / EMA / TGA / PMDA. At least involved in any of the foreign regulatory Inspection
  • Experience in ERP, TrackWise & LIMS system
Teva's Equal Employment Opportunity CommitmentTeva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws. We are committed to a diverse and inclusive workplace for all. If you are contacted for a job opportunity, please advise us of any accommodations needed to support you throughout the recruitment and selection process. All accommodation information provided will be treated as confidential and used only for the purpose of providing an accessible candidate experience.

Teva Pharmaceuticals

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Job Detail

  • Job Id
    JD3629127
  • Industry
    Not mentioned
  • Total Positions
    1
  • Job Type:
    Full Time
  • Salary:
    Not mentioned
  • Employment Status
    Permanent
  • Job Location
    Gwalior, Madhya Pradesh, India
  • Education
    Not mentioned
  • Experience
    Year