Manager/ Senior Manager - Central Quality - IV - API

Zydus Healthcare Limited; Ahmedabad District; On-site; INR 1,800,000 - 3,600,000; Full time

Job summary

Zydus Lifesciences in Ahmedabad, Gujarat, invites applications for Manager/Senior Manager - Central Quality - IV for API manufacturing (formulation) at Moraiya site, with 14–23 years of experience.

The role centers on monitoring QMS compliance, supporting regulatory audits, reviewing CAPA, and ensuring adequacy of site quality documentation, validation and vendor audit activities.

Responsibilities

• Facilitate monitoring of compliance to QMS norms and preparation of monthly quality reports of sites.
• Support regulatory activities, SME audits and preparation/review of audit responses.
• Assist in investigation of failures and repeated failures at the site.
• Review global CAPA, regulatory commitments, and their implementation and effectiveness at API sites.
• Oversee API site quality management system documents for adequacy and completeness (OOS/OOT, market complaints, returns, recalls).
• Review API site validation/qualification documents (equipment, utilities: N2, air, water, HVAC).
• Review periodic utility trends reports (N2, air, water, HVAC, breakdown) for adequacy.
• Support vendor qualification and audit of KSM/API and ensure traceability to vendor audit cell.
• Prepare and implement CQ policies and directives at sites.
• Periodically audit online documentation to identify recurring issues.
• Review site compliance reports and ensure closure with supporting documents/addenda.
• Identify areas of improvement from emerging trends.
• Review other QMS reports as required.

Job description

Job Description

Manager/ Senior Manager - Central Quality - IV - API CENTRAL QUALITY Manufacturing-formulation|for.mfg.moraiya, Ahmedabad, Gujarat, India 14 - 23 Years

Sr.No.

Job Responsibilities

1. 1. Facilitatemonitoring of compliance to QMS norms and preparation of monthly qualityreports of sites.
2. 2. Supportfor regulatory, SME audit and Facilitate for preparation of audit responseand review of response.
3. 3. Supportfor failure and repeated failure investigation to site.
4. 4. Review of global CAPA, regulatorycommitments, its implementation and effectivenessat API sites.
5. 5. Overviewof Quality Management System documents at API sites for ensuring its adequacyand completeness.
   • Out of specificationand Out of trend
   • Market complaint,Return and Recall
6. 6. Overviewof API site validation and qualification documents for ensuring its adequacyand completeness i.e.
   • EquipmentQualification and
   • Utilitiesqualification (N2, Air, Water and HVAC)
7. 7. Reviewof periodic trends report of utility (N2, Air, Water and HVAC, Breakdown) forensuring its adequacy and completeness.
8. 8. Supportfor vendor qualification and vendor audit of KSM/API and its traceabilitywith respect to compliance to vendor audit cell.
9. 9. CQpolicy and directive preparation, review and its implementation at sites.
10. 10. Periodicauditing of online documentation to identify and address recurring issues.
11. 11. Reviewof site compliance report as applicable and follow ups for adequate closurethrough appropriate supporting documents and addendum reports from site.
12. 12. Identifyspecific areas of improvement based on the emerging trend.
13. 13. Review of other QMS reports bysite based on the requirements i.e. consolidated reports, assessment summaryetc.

Job Snapshot

Location

Location Manufacturing-formulation|for.mfg.moraiya, Ahmedabad, Gujarat, India

At Zydus Lifesciences, w e nurture a culture of innovation, excellence, and inclusivity , driving meaningful advancement in the pharmaceutical and healthcare industries. Fueled by creativity , we constantly exploring new ways to improve patient care and expand healthcare accessibility.

Our commitment to a positive and empowering work environment has earned us recognition as one of India's Best Workplaces in Biotechnology & Pharmaceuticals.