Manager - DQA

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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

Manager - DQA

Job Description

Development Quality, New Products and NDSRI related activities

• Oversee and support the overall activities during the product development life cycle from Quality perspective in R&D (API and intermediates)
• To judge and understand the site needs with respect to system establishment and sustainability.
• Author / Review the SOPs/work directions required for implementing the Quality Systems in R&D activities as per GLP and regulatory requirements. Ensure effective implementation of SOPs/ work directions.
• Review and approve technology transfer, product specification, analytical method validation, method transfer, qualification, calibration, process validation protocol and reports. Ensure effective execution of these activities.
• Periodic audits of R&D laboratory. Ensure online documentation and review lab notebooks, PDR/LFR documents, analytical documents and stability data.
• Effective maintenance of R&D records, distribution and archival systems
• Perform cGMP audit of R&D facilities and operations. Assist the team in auditing contract manufacturers / vendors / contract testing laboratory.
• Coordinating in responding to all customer queries / audit findings related to R&D department. Institutionalize a system and track timely closure of CAPAs and audit findings
• Ensure R&D team practices, systems and documentation are in compliance with respect to data integrity norms.
• Implement systems for Change Control and Lab investigations in R&D.
• Ensure R&D team is trained for their relevant job function and GMP / GLP training.
• To handle customer and regulatory audits.
• Provide quality related inputs to new projects, existing project, up gradations etc.
• Participate in identification of Key Starting Material (KSM) / Registered Starting Material (RSM) and ensure that it is correctly identified.
• Participate in handling of Out of Specification, Out of Trends, Deviation, Batch failure, Rejections, investigations and CAPA implementation at site.
• Establish raw material standards by studying manufacturing / R&D requirements -conferring with suppliers.
• Responsible to follow the safety and environmental procedures deployed in the site.
• Coordination and support Regulatory Affairs team during dossier submissions.
• Review in line with the current expectations of QbD in product development.
• Review the Product development reports and evaluation of the CPPs and CQAs.
• Evaluate the feasibility of the new product requirements and supports in planning the design of experiments
• Communication and co-ordination with the customers in R&D related documentations like development reports, stress studies and method validation reports