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Senior Executive

3.00 to 5.00 Years   Hyderabad   28 Oct, 2020
Syngene International Limited
Job LocationHyderabad
EducationNot Mentioned
SalaryNot Disclosed
IndustryEducation / Training
Functional AreaExecutive Assistant (EA)
EmploymentTypeFull-time

Job Description

Designation : Senior ExecutiveJob Location : MangaloreDepartment : Quality AssuranceEfficiently review the documents pertinent to batch release and ensure compliance to laid down procedures.Key Responsibilities: (Maximum 5-8 Points)

  1. Review of executed batch manufacturing records, batch packing records, batch cleaning records.
  2. Review and ensure closure of QMS records related to the batch and where open, with due justification, before release of the batch.
  3. Review of audit trail records of the GMP computerized systems as part of the batch release.
  4. Ensure online trending of critical process parameters, critical in-process controls, critical quality attributes and report the deviations to the normal operating ranges.
  5. Ensure the quality management system documents are appropriately addressed prior to release the batch.
  6. Responsible to verify the weights of the dispatch material as per the batch packing record.
  7. Verify the customer agreements for compliance and ensure the agreements are followed all the time.
  8. Responsible to follow the Good documentation practices, Data integrity principles, company policies and regulations.
  9. Ensure collection of requisite quantity of retention samples
  10. Release of the batch in accordance to laid down procedure.
  1. Review of specifications, manufacturing, packing, quality control records pertinent to the batch
  2. Review of quality agreement pertinent to the client for whom the batch/es are manufactured.
  3. Review of QMS documents (change control, deviation, OOS, LIR, Investigations reports, CAPA etc.) related to the batch.
  4. Ensure closure of the QMS documents, as applicable before release of the batch
  5. Ensure online trending of critical process parameters and critical quality attributes related to the product.
  6. Ensure collection of requisite quantity of retention samples
  7. Release of the batch in accordance to laid down procedure.
  1. Evaluate and clear the line for Manufacturing, Packing, Quality Control testing as per approved procedures
  2. Ensure assurance on execution of manufacturing, packing, quality control testing, and Engineering & Maintenance processes as per laid down procedures
  3. Ensure assurance of online documentation of activities
  4. Ensure assurance of investigation of root cause and implementation of CAPA in the event of failures / observed non-compliances during internal and external audits
  5. Evaluate effectiveness of implemented CAPA.
Educational Qualification:
  1. M.Sc Chemistry
Technical/functional Skills: (Maximum 4-6 Points)
  • 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
Experience:
  • 3-5 years of experience in API Manufacturing plant
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
,

Keyskills :
missalescustomer relationscustomer servicedeliveryequal employment opportunitycontinuous improvement facilitationdrugscosmeticsquality management system

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