Piramal Pharma

CDMO and hospital generics, consumer health

Senior Executive-Quality Assurance

Regulatory & Quality (Life Sciences)Confirmed live in the last 24 hours

Full-timePithampur Industrial Area, Pithampur, Madhya Pradesh, IndiaNo salary listedIn-person

About the Job

Responsibilities

Prepare, execute, and review protocols for equipment qualification and computer system validation, area and HVAC qualification, and utility qualification, including temperature mapping for non-sterile and sterile areas as per the VMP.
Prepare BMR/BPR as required.
Prepare and execute CMP and CML for validation instruments.
Coordinate with cross-functional teams and customers to complete validation activities on time.
Coordinate with third-party validation vendors to complete validation and qualification activities on time.
Perform IT supplier assessments, periodic reviews, and audit trail reviews.
Handle onboarding, training, and offboarding of vendor/supplier service staff.
Handle media fill activities, SIP validation, and personnel qualification.
Handle internal and external audits.
Provide compliance responses to audit findings and ensure appropriate corrective actions.
Handle TrackWise and ENSUR activities, including document initiation.
Handle QMS activities, including incident, deviation, and CAPA investigations.
Maintain documents according to site procedures, including archiving and disposition.
Support the site DICO in monitoring and implementing data-integrity awareness actions.
Complete EHS activities on time, support EHS activities as required, and report near misses and incidents according to EHS requirements.
Attend onsite and offsite training sessions and provide training to relevant personnel.
Execute other duties as instructed by superiors.

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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-QA

Job Description

• Preparation, execution and review of protocols for Equipment qualification, Area and HVAC qualification, Utility Qualification including temperature mapping for Non-Sterile and Sterile area as per VMP.
• Perform media fill and SIP Validation
• To perform the Risk assessment as per ICH Q9, along with impact assessment of Change controls.

Key Roles/Responsibilities:

Preparation, execution and review of protocols for Equipment qualification & Computer system Validation, Area and HVAC qualification, Utility Qualification including temperature mapping for Non-Sterile and Sterile area as per VMP.
Preparation of BMR /BPR as and when required.
Preparation and Execution of CMP and CML for Validation Instruments.
To coordinate with cross functional team and customer for timely completion of validation activities.
To coordinate with Vendor (third party for validation) for timely completion of validation/qualification activities.
To perform the IT Supplier Assessment, Periodic review, and Audit trail review.
To carry out the On-Boarding, training, and Off-boarding of service staff provided by the Vendor/Supplier Organization.
Handling of Media fill related activity, SIP Validation and personnel qualification.
Handling of Audits, Internal as well as external.
To provide compliances against audit findings and to ensure appropriate corrective actions based on audit findings.
Handling of Track Wise related activities and ENSUR related activities (Initiation of documents).
Handling of QMS Activities (Incident, Deviation, CAPA Investigation etc.).
Maintaining documents as per as per site procedures, Archival and disposition of documents.
Support to site DICO (Data Integrity Compliance Officer) for monitoring and implementation of actions related to Data Integrity awareness at site.
To ensure the EHS (Environment, health and safety) related activities to be completed on time and to support EHS activities as per requirement. To report near miss and incidences as per EHS requirement.
To attend training session (onsite/ offsite) and provide training to concerned personnel.
Handling/ execution of other job as per the instructions of the superiors.

About the Company

Piramal Pharma

CDMO and hospital generics, consumer health

Piramal Pharma is a diversified pharmaceutical group with three divisions: Piramal Pharma Solutions (PPS), Piramal Critical Care (PCC), and the Consumer Products Division (CPD). PPS operates as a contract development and manufacturing organization, providing development and manufacturing services across the drug lifecycle for clients in North America, Europe, and Asia through a globally connected network. PCC specializes in complex hospital generics, particularly inhaled anesthetics, serving markets in the USA, Europe, and over 100 countries. CPD leads consumer healthcare in India with brands such as Littles, Lacto Calamine, i-pill, Tetmosol, Polycrol, and Tri Activ, and the company serves pharmaceutical companies, hospitals, and consumers by leveraging its manufacturing scale and distribution network.

Company size: 1,001-5,000
Company stage: IPO
Headquarters: Maharashtra, India
Founded: 2020

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