Position: AM – Quality Assurance
Location: Dhanaura, Uttar Pradesh, India
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(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)
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)
Apply: Click here to Apply
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