Manager - Quality at Shalina Healthcare

Job Overview

Location
Lagos, Lagos
Job Type
Full Time
Date Posted
9 months ago

Additional Details

Job ID
128165
Job Views
103

Job Description






What to expect:




  • Responsible for QA/QC function.

  • Responsible for Implementation of Shalina QMS.

  • To approval APQR, SMF, VMP, PV & CV as per SHNL QMS policy.

  • Monitoring Qualification, Validation and calibration Activities.

  • Identification & Assessment of Risk and execute the mitigation plan.

  • Investigation of market complaints & ensure effective implementation of CAPA. Carryout periodic reviews.

  • Approval of MBMR, MBPR & IP specifications.

  • To Review and approve Change Control, OOS, OOT, Deviation / Rejection and ensure CAPA.

  • Review of Manuals, Policy Documents, SOP’s & their revisions.

  • To prepare and execute effective Training plan for staff & workmen.

  • To prepare monthly Quality Index for QA & site.

  • Monitoring & review of daily IPQA activity.

  • To conduct self-inspection program & ensure all time readiness for external audits.

  • To monitor Cleaning, Sanitation & hygiene in all departments and ensure all time GMP compliance of plant.

  • Prepare, execute & submit audit compliance for regulatory audit of site.

  • Release of finished product for sale and distribution.

  • Release of raw materials and packaging materials for use in manufacturing.

  • Rejection of none conforming raw materials, packaging materials, intermediary materials and finished goods.

  • To maintain the plant in state of compliance to ensure all the time readiness for audit.

  • Ensure effective co-ordination with different dept. for smooth functioning



Preferred candidate profile




  • 10+ years of experience.

  • Candidates from pharmaceutical industry shall be preferred.

  • Deep understanding of ISO (e.g., SAHPRA, PICs, WHO, ISO 9001, ISO 13485), GxP, GMP, FDA, ICH, or other applicable regulatory frameworks depending on the industry.

  • Proficient in implementing, auditing, and maintaining QMS frameworks

  • Strong writing skills for audit reports, SOPs, and compliance documentation

  • Strong problem-solving mindset to assess data, detect patterns or risks, and draw meaningful conclusions.

  • Deep understanding of relevant industry regulations.



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