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1 Symbiance Pharma Solutions Job

Associate Director - Quality Assurance

10-20 years

Chennai

1 vacancy

Associate Director - Quality Assurance

Symbiance Pharma Solutions

posted 21d ago

Job Role Insights

Flexible timing

Job Description

Provide overall leadership for the functions and responsibilities to establish comprehensive quality processes and systems. Manage the quality assurance oversight of Symbiance projects, assignments, training, and staff.
Provide insights, analyses, and support in the assessment and promotion of compliance with regulations, guidelines, and operating procedures, risk identification, and mitigation quality, process, productivity/efficiency improvement initiatives.
Oversee & coordinate assigned QA activities in support of customers, functionals, audit and inspection programs, or QA quality management system at a global level.
Essential Functions
  • Provide guidance, interpretation, support, training, and key input s consultation and interpretation of regulations, guidelines, corporate standards, and policies.
  • Provide Quality Assurance support, guidance, and management of Quality Issues, as assigned.
  • Assist in the enhancement of Quality Assurance and control policy, and risk identification and mitigation by providing consultation & recommendations to projects.
  • Plan, conduct, report, and follow-up of internal audits, in accordance with current SOP(s) and participate in the review of corrective action plans, as assigned
  • Oversee proper coordination of customer-initiated audits and mock regulatory inspections, manage regulatory inspections, as assigned
  • Support Inspection Readiness Activities
  • Participate in or lead (cross functional) teams for special projects as assigned
  • Promote the concept of quality, the principles of quality management and devise and implement quality improvements
  • Provide suggestions for continuous quality improvement in GCP.
  • Review relevant project documentation for compliance with GCP and corporate standards
Skills & Qualifications
  • Full time - Bachelors Degree Preferably
  • 10 years experience Quality Assurance experience in pharmaceutical, technical, or related area including GCP Quality Assurance auditing experience. Equivalent combination of education, training, and experience.
  • Experience in working for ISO QMS and ISMS audits is a must.
  • Strong knowledge of pharmaceutical and CRO processes and regulatory environments.
  • Possess applicable experience in conducting audits, writing audit reports and analyzing audits.

Employment Type: Full Time, Permanent

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What Symbiance Pharma Solutions employees are saying about work life

based on 9 employees
67%
100%
100%
Flexible timing
Monday to Friday
No travel
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Symbiance Pharma Solutions Benefits

Free Transport
Child care
Gymnasium
Cafeteria
Work From Home
Free Food +6 more
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