About this role
Quality Assurance Executive
To support Quality Assurance activities including QMS coordination, quality documentation, qualification, validation, batch-related quality review and audit compliance activities.
KEY RESPONSIBILITIES
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To co-ordinate, handle and review of change control, deviation, market complaint, OOS, OOT, returned goods, CAPA, QRM, product recall and other QMS related activities. To prepare & review SOPs and other quality related documents as per the requirement. To review the specification / method of analysis / test report.
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To prepare & review the quality documents (SMF/VMP/QM etc.) & it’s up-dation. To prepare & review the Technical Agreement / Quality Agreement. To prepare & review QMS trends.
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To perform the qualification of equipment, instrument and validation for process & cleaning as per ICH Q7 guideline.
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To co-ordinate for dispatch related activity. To handle the return goods / Recall. To prepare & review APQR. To review TR & COA before batch release
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To coordinate and fill customer questionnaire. To coordinate for customer queries. To Co-ordinate for Quality Agreement / Technical Agreement. To prepare & review the site quality risk assessment. To coordinate for external communication.
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To co-ordinate for audit compliance report of various customer. To coordinate for QMR related activity. To conduct vendor audit.
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QUALIFICATIONS & EXPERIENCE
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B.Pharm./B.Sc./HND in Biochemistry, Microbiology or a related discipline.
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5-8 years of Quality Assurance experience in the pharmaceutical API or regulated chemical manufacturing industry.
WHAT WE OFFER
Competitive salary and performance-based bonuses. A supportive and dynamic work environment with clear career growth opportunities. Comprehensive medical insurance, pension, and other employee benefits.
Check how your CV matches this job
ROLE SUMMARY
To support Quality Assurance activities including QMS coordination, quality documentation, qualification, validation, batch-related quality review and audit compliance activities.
KEY RESPONSIBILITIES
-
To co-ordinate, handle and review of change control, deviation, market complaint, OOS, OOT, returned goods, CAPA, QRM, product recall and other QMS related activities. To prepare & review SOPs and other quality related documents as per the requirement. To review the specification / method of analysis / test report.
-
To prepare & review the quality documents (SMF/VMP/QM etc.) & it’s up-dation. To prepare & review the Technical Agreement / Quality Agreement. To prepare & review QMS trends.
-
To perform the qualification of equipment, instrument and validation for process & cleaning as per ICH Q7 guideline.
-
To co-ordinate for dispatch related activity. To handle the return goods / Recall. To prepare & review APQR. To review TR & COA before batch release
-
To coordinate and fill customer questionnaire. To coordinate for customer queries. To Co-ordinate for Quality Agreement / Technical Agreement. To prepare & review the site quality risk assessment. To coordinate for external communication.
-
To co-ordinate for audit compliance report of various customer. To coordinate for QMR related activity. To conduct vendor audit.
-
QUALIFICATIONS & EXPERIENCE
-
B.Pharm./B.Sc./HND in Biochemistry, Microbiology or a related discipline.
-
5-8 years of Quality Assurance experience in the pharmaceutical API or regulated chemical manufacturing industry.
WHAT WE OFFER
Competitive salary and performance-based bonuses. A supportive and dynamic work environment with clear career growth opportunities. Comprehensive medical insurance, pension, and other employee benefits.
Check how your CV matches this job