Job Responsibilities:
Accountable for QA/QC operations.
Responsible for Implementing Shalina Quality Management System.
To endorse APQR, SMF, VMP, PV & CV in accordance with SHNL QMS guidelines.
Overseeing Qualification, Validation and calibration Activities.
Recognizing & Evaluating Risks and implementing mitigation strategies.
Examining market complaints & ensuring effective CAPA implementation. Conduct regular reviews.
Endorsement of MBMR, MBPR & IP specifications.
To Evaluate and approve Change Control, OOS, OOT, Deviation / Rejection and ensure CAPA.
Examination of Manuals, Policy Documents, SOP's & their revisions.
To develop and execute effective Training plans for staff & workers.
To generate monthly Quality Index for QA & site.
Overseeing & reviewing daily IPQA activities.
To implement self-inspection program & ensure constant readiness for external audits.
To supervise Cleaning, Sanitation & hygiene across all departments and ensure continuous GMP compliance of plant.
Prepare, execute & submit audit compliance for regulatory inspection of site.
Authorize finished product for sale and distribution.
Approve raw materials and packaging materials for use in production.
Reject non-conforming raw materials, packaging materials, intermediary materials and finished goods.
To maintain the facility in a state of compliance to ensure constant readiness for inspection.
Ensure effective coordination with various departments for smooth operations
Ideal candidate profile
10+ years of relevant experience.
Applicants from pharmaceutical industry will be given preference.
Comprehensive understanding of ISO (e.g., SAHPRA, PICs, WHO, ISO 9001, ISO 13485), GxP, GMP, FDA, ICH, or other applicable regulatory frameworks depending on the sector.
Skilled in implementing, auditing, and maintaining QMS frameworks
Excellent writing abilities for audit reports, SOPs, and compliance documentation
Strong problem-solving mindset to evaluate data, identify patterns or risks, and draw meaningful conclusions.
In-depth knowledge of relevant industry regulations.
How To Apply
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Attach your Application letter, updated Curriculum Vitae (CV) and any supporting documents required.
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Make sure to send your application before the closing date.
Note: Only shortlisted candidates are contacted.
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