Quality Assurance | Jubilant Ingrevia Limited | Dhanaura, Uttar Pradesh, India

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Position: AM – Quality Assurance

Location: Dhanaura, Uttar Pradesh, India

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Summary of Job

(Purpose/ objective of the job Department Organogram to be enclosed)

  • candidate is required having complete experience in API/Bulk/ Intermediates industries as per global regulatory requirements and responsible for implementation & compliances of 21CFR-Part11, ICH-Q7A, cGMP, WHO-GMP, ISO9001, FSSC, HACCP / global QMS requirements at SEZ site.

Key Responsibilities

(Performance Indicators)

  • Regularize the QC activities as per cGMP requirements.
  • Regulatory & Pharmacopeia requirement for lab compliance.
  • Review of hybrid & electronic data for IPQC & FG analysis.
  • Analytical method validation, OOS & OOT.
  • Knowledge about IMS system (ISO 9001:2015, ISO 14001:2015 OHSAS 18001:2007, and cGMP.
  • Analytical skill for QC instrument, i.e. GLC, HPLC, UV-Visible, FTIR, ICP, K/F, Melting point etc.
  • Co-ordination with QC staff, R&D, Commercial and production for quality & dispatch related activities for on time dispatches.
  • Resolve the trouble shooting related to QC activities.
  • Training to subordinate & employment of 21 CFR Part 211, 111 with data integrity (Part-11) compliance in lab.
  • Awareness about responsible care (Environment, Health, Safety and Security)
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No. of Reportees

2-3 numbers

Qualification & Experience

M.Sc. (Chemistry) with 8-12 yrs.

y Competencies (Technical, Functional & Behavioral)

  • Responsible for implementation & compliances of 21CFR-Part11, ICH-Q7A, cGMP, WHO-GMP.
  • Hand-on experience as Reviewer of electronic data & hybrid system in regulatory environment (US-FDA, WHO etc.)
  • Knowledge about 21 CFR Part 211, 111 with data integrity (Part-11)

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