Associate Manager - External Quality | Shalina Laboratories Pvt

Shalina Healthcare; Navi Mumbai; On-site; INR 1,500,000 - 2,100,000; Full time

Job summary

Shalina Healthcare is seeking an Associate Manager External Quality to oversee quality compliance and operations at contract manufacturing sites. The role ensures GMP adherence, supports product quality, and coordinates between internal and external stakeholders.

The candidate will perform FG inspection, batch release, IPQA across OSD and sterile formulations, and drive APQR preparation while maintaining strong cross-functional collaboration and willingness to travel extensively.

Qualifications

• 10–12 years of relevant experience in pharmaceutical quality operations.

Responsibilities

• Oversee quality operations at CMOs 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, capsules, OSD, oral liquids, external and sterile formulations.
• Monitor shop floor activities to ensure GMP compliance.
• Execute and review process validation and stability studies.
• Prepare APQRs.
• Witness manufacturing processes and finished product analysis.
• Conduct quality audits of CMOs and track actions.
• Manage relationships and coordination with CMOs.

Skills

GMP knowledge

Stakeholder communication

Cross-functional collaboration

Decision making

Education

B.Pharm / M.Pharm or Science graduate with relevant experience

Job description

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.

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

• 1012 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

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