Manager - Quality at Shalina Healthcare

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.