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Manager - Quality Assurance - Chemical Development

10.00 to 12.00 Years   Delhi   11 Jun, 2021
Syngene International Limited
Job LocationDelhi
EducationNot Mentioned
SalaryNot Disclosed
IndustryEducation / Training
Functional AreaBio Tech / R&D / Scientist
EmploymentTypeFull-time

Job Description

  • To handle FDA inspection and explain quality system along with all quality related documents directly.
  • To handle review of batch manufacturing record, qualification and validation documents.
  • To implement of all SOPs and if any deviation, is reported and investigated adequately in timely manner.
  • To ensure adequate closure of all QMS within timeline.
  • To ensure Market compliant are closed adequately in timely manner.
Key responsibilities:
  • Responsible for any time readiness of manufacturing site.
  • Able to handle FDA inspection and explain quality system along with all quality related documents directly.
  • Responsible for review of batch manufacturing record, qualification and validation documents.
  • Responsible for implementation of all SOPs and if any deviation, is reported and investigated adequately in timely manner.
  • Adequate closure of all QMS within timeline. Investigation are adequate with respect to root cause, CAPA and impact assessment.
  • Market compliant are closed adequately in timely manner.
  • Batches are released in time and without any discrepancies. No complaint from client.
  • To ensure Manufacturing is carried out as per GMP requirements. Any discrepancies are reported and closed in timely manner without impacting quality of batch. No audit observation.
  • To provide training to IPQA team on GEMBA walk to identify observations with respect to GMP and SOP vs practice to ensure any time audit readiness.
  • Adequate planning of planned internal/external audit, hosting of audit to ensure no Major and Critical observations. No repeat observations in the internal audit.
  • Ensure process and cleaning validation are carried out as per protocol.
  • Involve in all major investigation and ensure adequate investigation are carried out.
  • To present quality overview and KPI compliance to management in governance forum.
  • Track all MOM items of QGF, BU meeting and present in next meeting.
  • Ensure training of all QA person are done in timely manner. 100% compliance.
  • Identify non-value added work and duplicate work for effective usage of work force.
  • Ensure Quality score card and KPI are tracked and met.
  • Ensure correct and adequate data are provided to quality head in timely manner for senior management quality reviews.
  • Ensure Shift management are done in line with manufacturing requirements.
  • Any gap in the quality system, practices and facility is identified and system put in place.
  • 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
  • Ensure environment, health, and safety (EHS) measures are imparted via training and adhered within the team.
Educational Qualification: Minimum M.Sc. in chemistryTechnical/functional Skills: Candidate should have exposure in API manufacturing and drug development. Experience: 10- 15 yearsBehavioral Skills:
  • Excellence in Communication
  • Conflict Resolution
  • Work-life balance
  • Time-Management
  • Self-improvement
  • Stress Management
  • Patience
,

Keyskills :
equal employment opportunitycontinuous improvement facilitationroot causeanimal healthconsumer goodsquality systemshift management

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