Job Location

Mumbai

Job Description

Overview of the job

To manage the day-to-day activity by ensuring quality and compliance at external manufacturing sites involved in manufacturing & supply of P&G Products, ensuring ongoing activity at external manufacturing sites following the Quality Management System as per Company Standards and Consumer Healthcare business meet customer expectations along with regulatory and legal requirements.

This role requires a degree in Pharmacy, management, FDA understanding or a related field preferred. Previous experience as a technical departments like Operation, R&D, Quality supervisor or a similar management position. Strong working knowledge of Quality Assurance department, Experience in Pharmaceutical industry, and management. Proficiency in Microsoft Office and data entry software

Your team

This role reports to Sr. Manager, Quality Assurance

How success looks like

Quality Assurance: Good manufacturing practices (GMP) involve securing manufacturing & supplies from the external manufacturing sites in a way that ensures products are always available in good condition, making it easier to find and retrieve products, Meeting all regulatory compliance and GMP practices.

Quality system management at external manufacturing sites: Activities for Technology transfer at sites, approval of technical specifications, Change Control Management, QSF Management, Investigations - Complaints Management, CAPA management, Assessment Management via any other tool as an when implemented.

Responsibilities of the role

Quality system management at external manufacturing sites:

Support for technology transfer.

Supplier management related, etc.

Support for review & approval of technical specifications.

Review & approval of validation and transfer documents.

Support in planning, supervising, and reporting of stability.

Activities for Change Control Management, QSF Management, Investigations - Complaints Management, CAPA management, Assessment Management via any other tool as an when implemented.

Support for self-inspection audits, CAPA compliance reports, etc.

Support in GxP training activities.

Support in Quality technical agreement management as an when required.

Support quality and compliance related projects for Contract Manufacturing sites.

Data compilation, reporting of scorecard.

Job Qualifications

Minimum of a Degree in Pharmacy - experience as a combination of Quality / R&D / Projects

Minimum of 8 years of experience in Technical departments like R&D, Quality, etc.

Experience in Pharmaceutical industry (FDA understanding)

Comprehensive demonstrated working knowledge of principles and concepts of Quality Assurance – including those related to risk-based approach and quality design (ICH Q8 – Q12)

Job Schedule

Full time

Job Number

R000120606

Job Segmentation

Experienced Professionals (Job Segmentation)