Manager – Development Quality Assurance (Dqa)

Piramal Pharma

8-15 years

preferred by company

Digwal, Telangana, India

Openings: 1 May 18, 2026

Job Description

Job Type: Full Time Education: M.Pharm/B.Pharm or M.Sc. Skills: CPC Certified, Data Analysis, Document Management, Life Science, Regulatory Compliance, Waterfall Model, Environment, Experiments Design, Health And Safety (Ehs), Laboratory Equipment, Manufacturing Process, Materials Science, Process Simulation, Sop (Standard Operating Procedure), Technical Writing, Wat, GCP guidelines, gmp knowledge, HSE Knowledge , Logistics and Transportation Management, Master Data, Operational Excellence, Sap Erp, supply chain management, Supply Planning, Warehouse Management

Manager – Development Quality Assurance (DQA)

Company: Piramal Pharma Solutions
Location: Digwal, Telangana, India
Job Type: Full-Time
Work Mode: Onsite
Industry: Pharmaceutical | Development Quality Assurance | API Development | CDMO | Regulatory Compliance | Life Sciences
Experience Required: 8–15+ Years (Freshers Not Eligible)
Educational Qualification: Master of Science (M.Sc) – Mandatory
Job Requisition ID: R00001863
Application Deadline: 20 May 2026

About the Company

Piramal Pharma Solutions is a globally recognized Contract Development and Manufacturing Organization (CDMO) delivering end-to-end pharmaceutical development and manufacturing solutions across the drug lifecycle. With integrated operations across North America, Europe, and Asia, the company serves innovator and generic pharmaceutical organizations through advanced expertise in API development, drug discovery, process development, clinical trial supply, finished dosage manufacturing, and specialized pharmaceutical technologies.

Job Overview

Piramal Pharma Solutions is hiring an experienced Manager – Development Quality Assurance (DQA) for its Digwal, Telangana facility. This strategic leadership role is ideal for senior pharmaceutical quality professionals with strong expertise in development quality assurance, API R&D quality systems, GLP/GMP compliance, data integrity, technology transfer review, audit management, QbD, regulatory documentation, and pharmaceutical development lifecycle governance.

The selected professional will oversee quality assurance activities across the entire R&D product development lifecycle, ensuring compliance, regulatory readiness, audit preparedness, quality system implementation, and customer quality support.

This opportunity is highly suitable for professionals from API manufacturing, pharmaceutical R&D, CDMO quality assurance, development compliance, and regulated pharmaceutical environments.

Key Responsibilities

Development Quality Oversight

Oversee quality assurance activities across the entire pharmaceutical product development lifecycle for APIs and intermediates.
Provide strategic quality oversight for R&D operations, new product development, and development compliance systems.
Assess site quality system needs and implement sustainable development quality frameworks.

Quality Systems & SOP Governance

Author, review, approve, and implement:
- Standard Operating Procedures (SOPs)
- Work instructions
- Development quality systems
- R&D compliance documentation
Ensure compliance with:
- Good Laboratory Practices (GLP)
- cGMP requirements
- Regulatory expectations
- Pharmaceutical quality governance standards

Technical Review & Quality Approval

Review and approve:

Technology transfer documentation
Product specifications
Analytical method validation reports
Method transfer documentation
Qualification protocols
Calibration records
Process validation protocols and reports
Development quality documentation

Ensure quality compliance across technical development activities.

R&D Audit Management

Conduct periodic audits of R&D laboratories and development operations.
Perform cGMP audits for R&D facilities and systems.
Support audits of:
- Contract manufacturers
- Vendors
- Contract testing laboratories
Drive audit readiness and compliance improvement initiatives.

Data Integrity & Documentation Compliance

Ensure R&D documentation practices comply with pharmaceutical data integrity standards.
Review:
- Lab notebooks
- PDR / LFR documents
- Analytical records
- Stability documentation
- Online documentation systems
Maintain archival, document control, and record distribution systems.

Investigations, CAPA & Change Control

Implement and manage systems for:
- Change control
- Laboratory investigations
- OOS (Out of Specification)
- OOT (Out of Trend)
- Deviations
- Batch failures
- Rejections
- CAPA implementation
Ensure timely investigation closure and compliance governance.

Customer & Regulatory Audit Management

Handle customer audits and regulatory inspections related to R&D functions.
Respond to customer queries, audit observations, and development quality concerns.
Coordinate CAPA responses and quality remediation plans.

Regulatory Affairs & Dossier Support

Partner with Regulatory Affairs teams during dossier submission activities.
Ensure development documentation aligns with regulatory filing expectations.
Support customer documentation requirements including:
- Development reports
- Stress studies
- Method validation documentation

QbD & Product Development Quality

Review development programs aligned with Quality by Design (QbD) principles.
Evaluate:
- CPPs (Critical Process Parameters)
- CQAs (Critical Quality Attributes)
- Feasibility of new product development opportunities
Support design of experiments (DoE) planning and development quality decision-making.

Training & Team Quality Enablement

Ensure R&D teams receive:
- GMP training
- GLP training
- Job function-specific quality training
- Data integrity awareness programs
Strengthen development quality culture across teams.

Supplier & Material Quality Support

Participate in identifying:
- Key Starting Materials (KSM)
- Registered Starting Materials (RSM)
Support raw material quality standard establishment in collaboration with suppliers and internal teams.

Safety & Environmental Compliance

Ensure adherence to site environmental, safety, and operational compliance procedures.

Educational Qualification

Mandatory:

Master of Science (M.Sc) in Chemistry / Pharmaceutical Chemistry / Analytical Chemistry / Organic Chemistry / Related Life Sciences Discipline

Preferred:

Additional pharmaceutical quality or regulatory certifications

Experience Requirements

8–15+ years of pharmaceutical quality assurance or development quality experience
Strong experience in:
- API R&D quality systems
- Development quality assurance
- Regulatory audit handling
- Data integrity governance
- Technology transfer quality review
- Pharmaceutical investigations and CAPA systems
CDMO or API manufacturing experience strongly preferred

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