Senior Executive - Quality Assurance

Piramal Pharma Solutions; Kohir mandal; On-site; INR 600,000 - 800,000; Full time

Job summary

Piramal Pharma Solutions invites applications for the role of Senior Executive - Quality Assurance. The candidate will handle QMS activities, including customer queries, complaints, change controls, OOS/OOT and audit compliance.

Responsibilities include managing customer audits, regulatory inspection support, CAPA, deviations, and preparation of quality review reports. MSc is required for this position.

Qualifications

• Master of Science (MSc) is required.

Responsibilities

• Handle QMS activities such as customer queries, complaints, change controls, OOS/OOT and audits.
• Manage customer/external audits and support regulatory inspections; prepare audit compliance reports.
• Handle customer complaints, queries and related documentation.
• Manage QMS events like CAPA, deviation, OOS/OOT, and change controls.
• Prepare/review Annual Product Quality Review and Continuous Process Verification reports.
• Oversee Return Goods activity and documentation.

Skills

QMS activities

Customer Queries

Complaints handling

Change Controls

OOS/OOT

Audit Compliances

Education

Master of Science (MSc)

Job description

Job Description:

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Division

Piramal Pharma Solutions

Piramal Pharma Solutions is a contract development and manufacturing organization (CDMO), offering end-to-end development and manufacturing solutions across the drug life cycle. We serve our clients through a globally integrated network of facilities in North America, Europe and Asia.

This enables us to offer a comprehensive range of services including Drug Discovery Solutions, Process & Pharmaceutical Development services, Clinical Trial Supplies, Commercial supply of APIs and Finished dosage forms. We also offer specialized services like development and manufacture of Highly Potent APIs and Antibody Drug Conjugation.

Our capability as an integrated service provider & experience with various technologies enables us to serve Innovator and Generic companies worldwide.

For more details, please visit : www.piramalpharmasolutions.com

Job Title

Senior Executive - Quality Assurance

Job Description

Handling of QMS activities i.e. Customer Queries, Complaints, Change Controls, OOS/OOT and Audit Compliances

• Completion of Customer Questionnaires, Desktop Questionnaires, Pre-Audit Questionnaire and share the declarations which are requested by customers.
• Handling of Customer/External audits and supporting to regulatory inspections. Prepare the audit compliance report against the audit observations received from customer.
• Handling the Customer Complaints, Customer Queries and its documentation.
• Handling of QMS events i.e. CAPA, Deviation, OOS/OOT, change controls etc.
• Prepare / Review the Annual product quality review and Continues process verification reports.
• Handling for Return Goods activity and its documentation.

Master of Science (MSc)

Requirements:

Master of Science (MSc)