Quality Assurance Manager, Anovent Pharmaceuticals (Recruitment Information of Shanghai Anovent Pharmaceutical Co.,)

Anovent Pharmaceuticals is an innovative company which is focusing on the research, development, production and sales of respiratory medicines. As an international pharmaceutical company in respiratory area, Anovent is dedicated to provide affordable respiratory medicines for patients worldwide.

Primary role of sales director is to lead Anovent quality assurance (QA) team, provide QA strategies and ensure QA objectives achieved successfully for Anovent products as the portfolio and organization expand.

Core Accountabilities/Responsibilities

Ø  Provide direction and guidance for development, improvement, implementation, and maintenance of the entire quality system for the company.

Ø  Lead internal and external audits to ensure compliance with current Good Manufacturing Practices (cGMP) in accordance with regulatory standards, and to ensure integrity of data to support regulatory filings.

Ø  Develop proactive approaches to implement quality standards, policies and procedures for cGMP regulatory compliance.

Ø  Facilitate cGMP training of functional areas and develop training sessions.

Ø  Participate in regulatory agency inspections of cGMP inspections and follow-up to resolve audit findings. 

Ø  Provide guidance on interpretation and application of cGMP regulations and guidance documents

Ø  Provide input to the preparation of documents for internal reports, external partner reports and/or regulatory filings, as needed.

Requirements

Ø  Master degree or above in related disciplines.

Ø  2+ years’ work experience in quality assurance of pharmaceutical industry or related area.

Ø  Generic drug experience highly preferred, especially in US ANDA.

Ø  DPI or inhalation product experience highly preferred.

Ø  Experience in a quality environment with expertise in cGMP.

Ø  Experience with documentation systems, document review and auditing responsibilities.

Ø  Strong knowledge of cGMP regulations. 

Ø  Good computer skills.

Ø  Strong ability in English, including listening, speaking, reading and writing.

Ø  Ability to operate in a fast-paced, multi-disciplinary industrial environment. 

Ø  Strong verbal and written communication skills and detail orientation required

Ø  Proactive, independent, hard-working and committed to achieving difficult goals. 

        Contact information

        Anna He     Tel: 13816142073      mail:annahe9999@126.com