Group Leader/Senior Team Leader - Quality Assurance

Onesource Specialty Pharma Limited

12 - 15 years

18 - 27 Lacs

bengaluru

Posted:1 month ago| Platform:

Apply

Skills Required

quality assurance capa

Work Mode

Work from Office

Job Type

Full Time

Job Description

Serve as Quality Lead for outsourced manufacturing operations (CDMO/LL), ensuring robust compliance with cGMP (FDA, EU, ICH, PIC/S).
Draft, review, negotiate, and manage Quality & Technical Agreements with contract manufacturers.
Oversee and approve Change Controls, Deviations, Investigations, and CAPA activities; ensure timely and risk-based closure.
Lead technical review and approval of batch documentation, including BMR/MMR, COAs, specifications, test methods, artworks, and master records.
Act as key interface between contract manufacturing sites, internal teams (Supply Chain, Regulatory, QC), and customers to resolve quality issues and queries.
Conduct or support audit readiness activities—supplier audits, internal/external quality audits and customer inspections.
Maintain and enhance elements of the Quality Management System (QMS)—document control, change management, training, vendor management, metrics and continuous improvement.
Where applicable, support process validation oversight, technology transfer activities, and product lifecycle documentation.

More Jobs at Onesource Specialty Pharma Limited

Manufacturing QMS (Sterile, DP & DS) - OneSource @Bangalore

Bengaluru

4 - 9 yrs

INR 0 - 0 Lacs

Associate Director-Electrical & Instrumentation

Bangalore Rural

17.0 - 25.0 yrs

INR 25 - 40 Lacs

QC-Product/GLP/Inprocess/Central Lab (Sterile)

Hyderabad, Chennai, Bengaluru

2.0 - 7.0 yrs

INR 3 - 8 Lacs

Regulatory Affairs-Sterile

Hyderabad, Chennai, Bengaluru

2.0 - 7.0 yrs

INR 3 - 8 Lacs

QC-Investigations/Central Lab-Sterile

Hyderabad, Chennai, Bengaluru

10.0 - 20.0 yrs

INR 10 - 20 Lacs

Mock Interview

Practice Video Interview with JobPe AI

Start Job-Specific Interview

Start Your Job Search Today

Browse through a variety of job opportunities tailored to your skills and preferences. Filter by location, experience, salary, and more to find your perfect fit.