3 Days Left) Development Quality Assurance Manager

4 weeks ago

Hyderabad, Telangana, India PI Health Sciences Ltd Full time
- Designation - Manager - DQA
- Exp - 8-12 years
- Location - Hyderabad Research Center
- Industry experience - CDMO Only.

Position Overview

The Manager – DQA will be responsible for leading the Drug Quality Assurance function in alignment with regulatory requirements, client expectations, and internal quality systems in a CDMO environment. This role involves overseeing all quality aspects of development, technology transfer, and manufacturing for multiple clients, ensuring that deliverables meet cGMP, ICH, and other applicable regulatory guidelines.

Key Responsibilities

1. Quality Oversight in Development & Manufacturing

- Manage quality assurance activities across drug product and drug substance development stages in a CDMO setup.
- Review and approve batch manufacturing records, analytical data, and process documentation.
- Oversee process validations, cleaning validations, and equipment qualification protocols/reports.

2. Client & Regulatory Interface

- Act as the quality point-of-contact for clients, supporting project reviews, quality discussions, and audits.
- Prepare and coordinate for regulatory inspections (USFDA, EMA, MHRA, WHO, etc.) and client audits.
- Ensure timely closure of audit observations and CAPAs.

3. Documentation & Compliance

- Ensure that all manufacturing and analytical activities comply with cGMP, ICH, and local regulatory guidelines.
- Review and approve quality documents such as SOPs, protocols, and reports.
- Oversee deviation, OOS/OOT investigations, and change control management.

4. Continuous Improvement & Risk Management

- Lead initiatives to improve quality systems and processes within the CDMO framework.
- Perform quality risk assessments and ensure preventive actions are implemented.
- Monitor quality KPIs and implement corrective actions to meet performance targets.

Qualifications & Experience

- Education: M.Pharm / M.Sc. in Pharmaceutical Sciences, Chemistry, or related field.
- Experience:
- Minimum 8–12 years in Quality Assurance within the pharmaceutical industry.
- At least 3–5 years in a CDMO or multi-client manufacturing environment.
- Strong exposure to regulatory inspections (USFDA, EMA, MHRA, WHO).
- Experience in handling late-phase development, tech transfer, and commercial manufacturing.
- Skills & Competencies:
- In-depth knowledge of cGMP, ICH Q-series guidelines, and global regulatory expectations.
- Strong leadership, communication, and client management skills.
- Ability to work in a fast-paced, project-driven environment with multiple stakeholders.

Key Performance Indicators (KPIs)

- Compliance metrics (deviation/CAPA closure timelines, audit findings).
- Client satisfaction scores.
- Timeliness and accuracy of document reviews and approvals.
- Readiness for regulatory and client inspections.

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