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Audit & Compliance

4.00 to 6.00 Years   Kolkata   18 May, 2021
Sygene
Job LocationKolkata
EducationNot Mentioned
SalaryNot Disclosed
IndustryPharma / Biotech
Functional AreaFinance / Accounts / Tax
EmploymentTypeFull-time

Job Description

Designation: Senior ExecutiveJob Location: Bangalore, Biocon ParkDepartment: Quality Assurance -BiologicsAbout Syngene Incorporated in 1993, Syngene International Ltd. is an innovation-focused global discovery, development and manufacturing organization providing integrated scientific services to the pharmaceutical, biotechnology, nutrition, animal health, consumer goods and specialty chemical industries around the world. Syngene s clientele includes world leaders such as Bristol-Myers Squibb, Baxter, Amgen, GSK, Merck KGaA and Herbalife. Its innovative culture is driven by the passion of its 4240- strong team of scientists who work with clients from around the world to solve their scientific problems, improve R&D productivity, speed up time to market and lower the cost of innovation.

  • Perform cGMP verification visit in Warehouse pertaining to Biologics Operations Unit to ensure compliance.
  • Support & facilitate the client and regulatory audits for the Biologics business unit.
  • Responsible for the documentation logistics for the audits and client visits.
  • Support in coordination of the writing of audit response with all cross functional team within the stipulate timeline.
  • Log, track and manage the Audit CAPAs.
  • Liaise with and support the Internal Audit and Continuous improvement team for the timely closure of the CAPA.
  • Trend the Audit CAPAs and the observation on a quarterly basis for identifying the repeated observation and their CAPAs.
  • Track CAPA effectiveness verification.
  • Provide training to required employees on various aspects such as Good Documentation Practices, Good Manufacturing Practices, Data Integrity and Aseptic practices as applicable.
  • Verification of the SAP related activities used by Warehouse, QC, and Manufacturing related to receipt, sampling, testing, shelf life assignment, releasing, dispensing, storage, retesting, control sample testing, reconciliation and disposal of RM/PM and consumables.
  • Inspection of Raw material (RM), packing material (PM) and manufacturing consumables for any damage/discrepancy possible during receipt, storage, dispensing and handling of these materials in Warehouse.
Key Responsibilities:
  • Responsible for the material management /Audit and compliance of the Biologics business unit.
Educational Qualification:
  • Master of Science / Master of Technology -Biotechnology/Bioprocess Engineering
Experience: 4-6 years of experience in Biopharma manufacturing/testing/compliance/Quality Assurance.Technical/functional Skills:
  • Knowledge on Biologics Manufacturing and testing compliance requirements.
  • Subject Matter expert on the Guidelines/regulations pertaining to Biologics.
  • Tactful communication.
Behavioral Skills:
  • Aggressive but assertive on task completion.
  • High influencing skills to complete the task at hand.
  • Ability to provide solutions for complex problems.
Equal Opportunity Employer: It is the policy of Syngene to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by applicable legislation or local law. In addition, Syngene will provide reasonable accommodations for qualified individuals with disabilities.,

Keyskills :
documentation practicesquality assurancecontinuous improvementsapequal employment opportunitymaterial managementregulatory auditslegislative relationscapacgmppacking material

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