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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