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

Job Description

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 quality control (QC) manager is to lead Anovent QC team, provide QC strategies and ensure QC objectives achieved successfully for Anovent products as the portfolio and organization expand.

Core Accountabilities/Responsibilities

Ø  Prioritize and delegate work functions to support timely testing and release of forecasted incoming samples, and coordinate cross-functional, intra-departmental and inter-departmental work assignments.

Ø  Manage all QC laboratory data to include, ensure all test methods comply with cGMP regulations and company policies, investigate laboratory anomalies, evaluate laboratory trends and archive raw data and results for easy retrieval.

Ø  Oversee laboratory supply and equipment ordering and maintain ordering within budgetary guidelines, and assure that the equipments are calibrated and qualified to the degree suitable for their intended use and regulatory requirements.

Ø  Prepare and review SOPs and department policies, and work closely with QA to implement procedures in compliance with regulatory requirements.

Ø  Manage all Quality Control personnel, which may include incoming associates, and ensure training is maintained and enforces adherence to SOPs.

Ø  Represent QC department in client and regulatory audits and participate in responses for audit observations.

Requirements

Ø  Master degree or above in Chemistry or related disciplines, PhD degree highly preferred.

Ø  2+ years’ experience of QC functions in pharmaceutical industry or related areas.

Ø  cGMP experience highly preferred.

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

Ø  DPI or inhalation product experience highly preferred.

Ø  Strong knowledge of cGMP, pharmacopeia methods and requirements, regulatory guidelines, etc.

Ø  Good computer skills and strong QC technique skills.

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

Ø  Excellent leadership skills.

Ø  Excellent verbal, written, interpersonal, organizational and communication skills.

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

Ø  Effective problem solving skills and results orientated.

Ø  Ability to effectively manage multiple projects to meet timeline, technical and quality requirements.

        Contact information

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