Assistant Manager - External Quality

Shalina Healthcare; Navi Mumbai; On-site; INR 2,000,000 - 3,500,000; Full time

Job summary

Shalina Healthcare is seeking an Associate Manager - External Quality to oversee quality compliance and operations across CMOs in India. The role ensures GMP adherence, supports product quality, and coordinates with internal and external stakeholders.

The candidate will supervise quality operations at contract manufacturing sites, perform batch review and release, and contribute to product quality improvements while traveling as required across India and internationally.

Qualifications

• 10–12 years of experience in pharmaceutical quality operations.
• Strong exposure to GMP environments and regulatory inspections.
• Hands-on shop floor quality operations.
• Willingness to travel extensively across India and internationally.
• Ability to make independent, real-time decisions in dynamic environments.

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

Skills

GMP compliance

Quality operations

Contract manufacturers

Regulatory inspections

GMP/GLP knowledge

Cross-functional coordination

Education

B.Pharm / M.Pharm

Science graduate

Job description

Shalina Healthcare is one of the largest pharmaceutical companies in sub-Saharan Africa. For the last 40 years we have made it our mission to provide quality medicines to those who need it the most. We manufacture and distribute branded prescription and over-the-counter pharmaceutical and consumer products, across a broad range of therapeutic groups, including anti-malarial, antibiotics, anti-inflammatory and nutrition. We have a track record few can match and our brands are among the most trusted in Africa.

We are proud of our history and have big ambitions for the future. Our vision for 2030 is to be the health champion of Sub-Saharan Africa. To achieve this, we are looking for the right people to join us and create a lasting impact not just within our company but on the communities we serve.

Everyone in our company has a crucial role to play, and we are looking for people who identify with our Core Values and are as passionate about our Mission as we are.

The Global Supply Organisation is a multi-continental Function that comprises of the entire Value Chain from product conceptualization to delivery to the commercial front. Within the Global Supply Organization are included; Research & Development, Project Management, Manufacturing, Quality, Supply Chain Management and Logistics.

Role: Associate Manager - External Quality

Reporting to : Sr. Manager - Quality

Role Overview

The Associate 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.

What to expect:

• 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:

• 10–12 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:

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