HomeProductionSr Executive - Quality Assurance | Syngene International | Bengaluru

Sr Executive – Quality Assurance | Syngene International | Bengaluru

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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.

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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.

Position: Sr Executive – Quality Assurance – Chemical Development

Location: Bangalore, Karnataka, India

Job Description:

  • Should be aware of QMS system to small molecule API facilities and participates in Initiation, review, and approval/ rejection of Change controls, deviations, & Risk assessments OOS investigation, Client’s or regulatory audit co-ordination, Audit CAPA initiation and follow-up and closure and Preparation, Review, and approval of the Quality agreement, APQR.  To comply with all the regulatory audits like USFDA, PMDA, WHO, EUGMP, TGA, and other regulatory agencies.  All the time ready for compliance with regulatory and Client’s expectations.
  • Responsible for Preparation, Review, and approval of VMP, Validation protocols, and report (Process, Analytical, and cleaning) and monitoring commercial validation batches and training for the execution of the validation.  Taking independent responsibility of Process and Cleaning validation of specific Client requirements in line with FDA, APIC & other regulatory guidelines on process, analytical & cleaning validation.  To attend regular tele conic and support Client’s expectations, provide on-time support to meet the specific timelines.  Must be having very good skills in assessing, writing, and finalization of investigations on any such process, cleaning, and analytical validation requirements in line with regulatory expectations.

  • Responsible for preparation & review of master/ Executed BMRs, PDRs, line clearance, dispatches followed by batch release. Implementation of the Quality management system in the Small molecule API/ intermediate facility.
  • Knowledge of new facility commissioning and Qualification, computerized system validation, routine qualification and validation, activity. Support to the calibration and preventive maintenance activity. Well-versed with preventive & breakdown maintenance, calibration, HVAC systems, utilities followed by any activities pertaining to projects and Engineering and maintenance.  Expertise in the specific guidelines like EU Annex 11, 21 CFR Part 11, GAMP 5, and expert in conducting the gap analysis of computerized systems.
  • Aware of the Quality System in the purchase and warehouse, participating in warehouse activities including receipt verification, line clearance, investigations, review, and approval of the procedure for the small molecule drug substance.
  • Vendor & Warehouse management, Cleaning & Process validation expertise, awareness of Quality management system as per current guidelines.
  • Follow environment, health, and safety (EHS) requirements always in the workplace ensuring individual and lab/plant safety.
  • Attend training on environment, health, and safety (EHS) measures imparted company.

Technical/Functional Skills:

  • The candidate must be aware of the Quality management system, process & cleaning validation, exposure of current quality guidelines, good knowledge of DI perspective,
  • Vendor & warehouse management, IPQA skills followed Equipment qualification,
  • Calibration related to Engineering & Maintenance supports.
  • Good investigation writing skills & good English speaking & writing skills.
  • Knowledge of CSV, EHSS is also preferred.

Behavioral Skills:

  • Intellectual adaptability, personal integrity, interested in self-learning & development, result-oriented, Quality conscious, customer-centric, result-focused,
  • To build good relationships with inter-department personnel.

Qualification:  M.Sc., M. Pharm with Total Quality Management (TQM) or equivalent

Experience: 4-6 years

Salary: Negotiable

Contact Details:

careers@syngeneintl.com

OR

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