Manager – DQA

Qvents.In; Kolkata Metropolitan Area; On-site; INR 1,500,000 - 2,500,000; Full time

Job summary

Piramal Pharma Solutions (PPS) seeks a Manager in Quality Assurance to oversee R&D product development from a quality perspective, including API/intermediates. You will author SOPs, ensure GLP/GMP compliance, and supervise audits and CAPAs.

Key responsibilities include reviewing tech transfer, specifications, validation activities, and supporting regulatory dossier submissions. MSc required with relevant API/R&D QA experience.

Qualifications

• Pharma QA, R&D experience.
• Type of Experience: Pharma API, R&D, DQA, QA experience.
• MSc degree.

Responsibilities

• Oversee product development lifecycle from Quality perspective in R&D (API and intermediates).
• Author/review SOPs/work directions for GLP/regulatory requirements and ensure implementation.
• Review/approve technology transfer, specifications, analytical method validation, transfer, qualification, calibration, and validation reports.
• Conduct periodic audits of R&D laboratory; maintain records and documentation; manage CAPA tracking.
• Perform cGMP audits of R&D facilities; audit contract manufacturers/vendors/labs.
• Respond to customer queries/audit findings; track closure of CAPAs.
• Ensure data integrity across R&D activities; implement Change Control and lab investigations.
• Assist in regulatory dossier submissions and product development reviews.

Job description

Designation : Manager

Function : Quality Assurance

Functional Area : Design QA

Job Role Summary : Development Quality, New Products and NDSRI related activities, Support in regulatory audits, dossier submission

Job Profile

• Oversee and support the overall activities during the product development life cycle from Quality perspective in R&D (API and intermediates)


• 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.


• 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.


• 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

Job Requirements

Pharma QA, R&D experience

Type of Experience : Pharma API experience, R&D, DQA, QA experience

Academic Qualifications : MSc

Job Post Link : https://tinyurl.com/mm23eken

• Full Time


• India | Telegana | Digwal


• Posted 2 days ago

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Piramal Pharma Solutions (PPS)