Manager - External Quality | Shalina Laboratories Pvt

Shalina Healthcare; Navi Mumbai; On-site; INR 1,800,000 - 2,600,000; Full time

Job summary

Shalina Healthcare in Navi Mumbai invites a seasoned Manager External Quality to oversee quality operations at contract manufacturing sites and ensure GMP compliance. You will support product quality, batch release activities, and coordination between internal teams and CMOs.

The role requires 12–14 years in pharmaceutical quality operations, hands-on shop floor experience, and willingness to travel domestically and internationally.

Qualifications

• 12-14 years of relevant experience in pharmaceutical quality operations
• Strong exposure to GMP environments and regulatory inspections
• Hands-on experience in shop floor quality operations
• Willingness to travel extensively across India and internationally
• Ability to make independent, real-time decisions in dynamic environments
• Strong cross-functional collaboration and stakeholder communication skills

Responsibilities

• Oversee and monitor quality operations at contract manufacturing sites across the assigned region
• Act as the regional quality representative for compliance and quality-related matters
• Perform finished goods inspection, batch record review, and batch release activities
• Review finished product data to support new third-party product launches
• Ensure IPQA across dosage forms including Tablets and capsules, Oral liquids, External preparations & Sterile formulations
• Monitor shop floor activities to ensure compliance with GMP standards
• Execute and review process validation and stability studies
• Prepare Annual Product Quality Reviews (APQR)
• Witness manufacturing processes and finished product analysis
• Conduct quality audits of contract manufacturers and track compliance actions
• Manage relationships and coordination with CMOs

Skills

Quality operations

GMP compliance

Stakeholder communication

Travel readiness

Education

B.Pharm / M.Pharm

Science graduate

Job description

Role Overview

Manager External Quality will be responsible for overseeing quality compliance and operations across contract manufacturing organizations (CMOs). The role ensures adherence to GMP standards, supports product quality, and drives effective coordination between internal and external stakeholders.

Role & responsibilities

• Oversee and monitor quality operations at contract manufacturing sites across the assigned region
• Act as the regional quality representative for compliance and quality-related matters
• Perform finished goods (FG) inspection, batch record review, and batch release activities
• Review finished product data to support new third-party product launches
• Ensure in-process quality assurance (IPQA) across dosage forms including: Tablets and capsules (OSD), Oral liquids, External preparations & Sterile formulations
• Monitor shop floor activities to ensure compliance with GMP standards
• Execute and review process validation and stability studies
• Prepare Annual Product Quality Reviews (APQR)
• Witness manufacturing processes and finished product analysis
• Conduct quality audits of contract manufacturers and track compliance actions
• Manage relationships and coordination with CMOs

Preferred candidate profile

• 12-14 years of relevant experience in pharmaceutical quality operations
• Strong exposure to GMP environments and regulatory inspections
• Hands-on experience in shop floor quality operations
• Willingness to travel extensively across India and internationally
• Ability to make independent, real-time decisions in dynamic environments
• Strong cross-functional collaboration and stakeholder communication skills

Qualification

• Bachelors or Master’s degree in Pharmacy (B.Pharm / M.Pharm)
• Or a Science graduate with relevant industry experience

Competencies

• In-depth knowledge of shop floor operations for OSD and sterile formulations
• Experience in handling and managing contract manufacturers
• Strong understanding of GMP/GLP requirements
• Strong problem-solving and decision-making abilities
• Effective communication and coordination skills