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.