Manager Quality Assurance – GCP | Sun Pharma | Mumbai

Job Description

Position Overview:

The QA GCP auditor will be responsible for (i) QMS and SOP management, (ii) Auditing SPARC processes, trial master files, investigator sites, and vendors, (iii) Ensuring quality activities are performed and documented in compliance with company policies and standards and all applicable regulations with supervisory oversight.

Responsibilities:

• Auditing SPARC processes, Trial master files (TMFs), investigator sites and vendors (eg. CROs/company service providers), database audits, and System audits under the guidance of the senior members of the QA department.
• Maintaining QMS and SOP management (SOPs, WIs, GDLs, and SPARCqms)
• Knowledge of ICH-GCP, and local and national regulatory requirements.
• To ensure quality activities are performed and documented in compliance with companies policies, SOPs, and all applicable regulations with minimal supervisory oversight.
• TO work on process improvement initiatives at SPARC.
• Work on QA department activities as per requirement.

Desired Candidate Profile:

Education Requirement:

B.Pharm / MSc / BAMS / BHMS within a scientific discipline with 5-6 years of experience in a CRO setup.

Experience Requirement:

• A minimum of 5-6 years working in the Contract Research Organization / Pharmaceutical / Biotechnology industry.

Additional Skills:

• Has an understanding of the conduct of clinical trials/studies, either working as an auditor or Clinical Research Associate with at least 4 to 5 years of GCP auditing experience preferably in relation to sponsor / CRO and Site audits.
• Experience in clinical operations and handling clinical trial essential documents is a must (preferred).
• Strong knowledge of local, national, and global regulatory requirements for clinical trials and ICH-GCP guidelines.
• Assist in SOP management.
• Assist in the development and implementation of the annual QA-GCP audit plan using a risk-based approach.
• Work with different teams for CAPAs. Skilled in computer skills specifically MS Word, MS Excel, and MS PowerPoint.
• Other systems (Eg. Document management / Quality Management System).

Department: Quality Assurance – GCP

Business Unit: Operational Excellence COE

Location: Andheri(E) Mahakali, Mumbai