Job Information
Sun Pharmaceuticals, Inc Deputy General Manager- CMO in India
Sun Pharma Corporate Quality Audit Department
Position: Deputy General Manager
Location: Mumbai
Reporting Manager Title: VP & Head Corporate Quality & Compliance
Department: Corporate Quality
Job Summary:
Responsible for overall quality oversight functions of contract manufacturing organizations responsible for manufacturing of site transfer products (Sun site & R&D) for US market.
Essential Job Functions:
Caused based & frequent visits of the CMO sites for review of process & practices.
Coordinate with Sun site, commercial, corporate quality audit & the CMO site as SPOC for activities related to product manufacturing and release and other technical issues.
To review & approve quality agreements between Sun Pharma & CMO site. Also, ensure qualified and approved external service providers are used.
To participate in new product launch evaluation and technology transfer.
To monitor & ensure timely closure of market complaints, quality alerts, recalls etc.
Review and approval of process validation, analytical validation, hold time study, stability study protocols & reports.
Tracking of open CAPAs and ensure effectiveness of CAPAs.
Review & approval of annual risk assessments.
To monitor & evaluate product remediation.
Tracking & implementation of new projects as CMO sites.
Review and approve SOPs as per Sun Pharma quality standards.
Ensure timely implementation of Pharmacopoieal changes & compliance.
To ensure timely release of batches in SAP system.
Requirements and Qualifications: Basic Qualification:
M.Sc./ B. Pharm / M. Pharm or equivalent.
Industrial Experience & Knowledge:
Total 22-25 years of experience in Production, Quality Assurance, Quality and compliance in sterile formulations manufacturing.
Knowledge of GMPs in both domestic and international regulatory environments. In-depth
knowledge of FDA guidances such as ICH is must.
Strong organizational, interpersonal and communication skills.
Ability to work effectively in multicultural matrix organization.
We provide equal employment opportunities for all current employees and applicants for employment. This policy means that no one will be discriminated against because of race, religion, creed, color, national origin, nationality, citizenship, ancestry, sex, age, marital status, physical or mental disability, affectional or sexual orientation, military or veteran status, generic predisposing characteristics or any other basis prohibited by law.