About this role
Emzor Pharmaceutical Industries Limited
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.