Manager / Senior Manager - QA

Piramal Pharma Limited; Navi Mumbai; On-site; INR 4,000,000 - 7,000,000; Full time

Job summary

Piramal Pharma Limited in Navi Mumbai is seeking an experienced QA Head IPQA to provide leadership for quality assurance on the shop floor. You will oversee QMS elements, approve deviations, OOS, CAPA, change controls, and ensure timely release or rejection of intermediates and APIs in line with GMP requirements.

The role requires strong expertise in cGMP, data integrity, and regulatory compliance, with hands-on review of SOPs, BMRs, validation documents, and support for process and cleaning

Qualifications

• Must have API manufacturing experience, preferably with peptide exposure.
• Strong exposure to Quality Management Systems (QMS) including Deviations, OOS, OOT, CAPA, Change Controls, Risk Assessments, Complaints, Recalls and Returned Goods.
• Solid knowledge of cGMP, Data Integrity and Regulatory Compliance requirements.
• Experience in review and approval of SOPs, BMRs, analytical records, specifications, protocols, reports and validation documents.
• Expertise in Process Validation, Cleaning Validation, Equipment Qualification, Utility Qualification and Computerised System Validation (CSV).

Responsibilities

• Provide oversight and approval for QMS elements including Deviations, OOS, OOT, CAPA, Change Controls, Risk Assessments, Complaints, Recalls, and Returned Goods.
• Ensure timely investigation, closure, and effectiveness verification of quality events.
• Authorize release or rejection of Intermediates and APIs in accordance with GMP requirements.
• Ensure compliance of manufacturing processes with approved procedures and regulatory expectations.
• Review and approve SOPs, specifications, batch records, analytical records, protocols, reports and other GMP documents.

Skills

QMS

Deviations

OOS

CAPA

Change Controls

Risk Assessments

Data Integrity

Regulatory Compliance

Job description

Role & responsibilities

• Provide oversight and approval for Quality Management System (QMS) elements including Deviations, OOS, OOT, CAPA, Change Controls, Risk Assessments, Complaints, Recalls, and Returned Goods.
• Ensure timely investigation, closure, and effectiveness verification of quality events.
• Authorize release or rejection of Intermediates, and APIs in accordance with approved specifications and GMP requirements.
• Ensure compliance of manufacturing processes with approved procedures and regulatory expectations.
• Review and approve SOPs, specifications, batch manufacturing records, analytical records, protocols, reports, and other GMP documents through electronic quality systems.
• Ensure robust documentation practices and adherence to Data Integrity principles.
• Review and approve validation protocols and reports, including Process Validation, Cleaning Validation, Equipment Qualification, Utility Qualification, and Computerised System Validation.
• Review and approve quality risk assessments associated with manufacturing processes and systems.
• Ensure compliance of calibration and preventive maintenance programs from a quality perspective.
• Lead the IPQA team, Ensure effective shop-floor QA oversight and escalation of critical observations.
• Lead and participate in regulatory agency inspections, customer audits, and internal audits.
• Coordinate audit preparations and ensure timely closure of observations through effective CAPA implementation.
• Conduct self-inspections and compliance assessments to identify and mitigate quality risks.
• Provide quality guidance for new projects, process improvements, and operational excellence initiatives.
• Coach and mentor team members to strengthen quality systems and compliance culture.
• Drive continuous improvement and quality culture initiatives across the site.
• Act as Head-QA designee in their absence and assume responsibility for all site QA activities.

Preferred candidate profile

• Must have experience in API (Active Pharamacetuicals Ingredients ) manufacturing, with preference given to candidates having exposure to peptide manufacturing.
• Strong exposure to Quality Management Systems (QMS) including Deviations, OOS, OOT, CAPA, Change Controls, Risk Assessments, Complaints, Recalls, and Returned Goods.
• Sound knowledge of cGMP, Data Integrity, and Regulatory Compliance requirements.
• Experience in review and approval of SOPs, BMRs, analytical records, specifications, protocols, reports, and validation documents.
• Expertise in Process Validation, Cleaning Validation, Equipment Qualification, Utility Qualification, and Computerized System Validation (CSV).