Senior Executive - Quality Assurance

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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
•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.
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