Senior Executive - QA (Microbiology)

Sentiss Pharma

6 - 9 years

7 - 9 Lacs

nalagarh

Posted:2 weeks ago| Platform:

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Skills Required

lab qa bet environmental monitoring injectables microbial limit test

Work Mode

Work from Office

Job Type

Full Time

Job Description

Role & responsibilities

In-depth knowledge of microbial techniques such as sterility testing, BET, Preservative Efficacy Test, Microbial Limit Test, Culture Identification, Growth Promotion Test, and Environmental Monitoring programs.
Proficient in soft skills and tools including MS Word, Excel, PowerPoint, LIMS, and MINITAB.
Skilled in trend data analysis using MS Excel, including histogram plotting, use of formulas, hyperlinks, and other advanced functions.
Excellent written and verbal communication skills in English.
Experienced in regulatory audits and interactions with inspectors as an SME for agencies such as US-FDA, MHRA, TGA, EU-GMP, ANVISA, Ukraine, and PIC/S.

Preferred candidate profile

Oversight of entire Microbiology laboratory as Lab QA to maintain the compliance in Microbiology Lab.
Review of microbiology documents like log books, analytical reports, SOPs, Validation protocols, EM reports, Change Controls, Investigation reports etc.
Colony Counting/Observation of Environment Monitoring Plates and other microbial analysis samples.
EM (Viable and Non-viable) Trend data preparation and analysis.
Handling of Microbial excursions (initiation, investigation and CAPA implementation of Out of Limit / Out of Alert excursions).
Handling of QMS (Event/Deviation, Change control, Risk Assessment, CAPA, Internal Audits).
Handling of audits (interaction with auditors as SME).

Must have 6-9 years in the Microbiology Laboratory of sterile formulation units.

Share CV on dgurjar@sentisspharma.com

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