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Required for Manager, Quality Assurance in Nektar

 

Clinical courses

Nektar Therapeutics is a clinical-stage biopharmaceutical company developing a pipeline of drug candidates that utilize its PEGylation and polymer conjugate technology platforms, which are designed to improve the benefits of drugs for patients. Its product pipeline consists of drug candidates across a number of therapeutic areas, including oncology, pain, anti-infectives, anti-viral and immunology. Nektar's research and development activities involve small molecule drugs, peptides and other potential biologic drug candidates. Its drug candidates are designed to improve the pharmacokinetics, pharmacodynamics, half-life, bioavailability, metabolism or distribution of drugs and improve the overall benefits and use of a drug for the patient.

Post: Manager, Quality Assurance (India)

Position Summary
Manage Development, implementation and maintenance of Quality Systems and related activities. Manage activities for generation and review of Quality System Documentation used particularly in Good Manufacturing Practices (GMP) including ICH analytical and stability requirements and on need basis according to Good Laboratory Practices (FDA and OECD principles). Management of schedule for internal audits, client (CRO or CMO) and external audits. Manage audits and reporting of in house studies in support to development programs in a timely manner. Participate in program team meetings, and assist in preparing documents for regulatory filings. Coordinates inter-site location activities.  Assist in resolving GxPs compliance related issues and improve efficiency. Assisting in selection, development, and evaluate personnel to ensure the efficient operation of the function. Contributes to and supports the company’s development programs. Leads direct report staff.

Responsibilities
Responsible for implementing and monitoring compliance to cGMP regulations. Evaluation of vendors including contract research organizations for regulatory compliance before contracting studies.  Review, compile, approve, control and distribute master schedules, SOPs and other quality documents. Review and release drug substance and drug product data packages for regulatory filings. Conduct study audit, review work plans, and test procedures, including verification of successful close out.  Review of deviations, changes and corrective and preventive actions program.  Review of validations and qualification documents. Over all supervision of archives and related activities and document control.  Coordinate and participate in internal Quality audits and follow-up audits.  Will provide assistance during inspections by regulatory agencies.  Effectively manage and motivate direct report staff- Interacts with internal and external stakeholders on quality matters.


Requirements
Masters degree in Biology, Chemistry or Pharmacy. Experience of 8-10 years working in Quality environment with a thorough understanding of GxPs (cGMP) is essential. Understanding on GLPs (FDA, OECD) would be added advantage. 3-5 years managerial experience is desirable. Comprehensive knowledge of GxPs with emphasis on ICH analytical and stability requirements for drug substance and drug product; and ability to correctly interpret regulatory guidelines/standards is a must (US FDA 21 CFR Part 210, 211, 58 and OECD). Experience with documentation systems and with document review and auditing skill. Working knowledge in quality sciences, statistics, and computer-based operations is required.  Verbal and written communication skills are required. Must be goal-oriented, quality-conscientious, and customer-focused. Experience working in a team-focused environment is preferred.  Must be detail oriented.

Additional Information:
Experience: 8-10 years

Education: Masters degree in Biology, Chemistry or Pharmacy
Location: Hyderabad
Job ID: IN2894-3460-2015
Industry Type: Pharma/ Biotech/Clinical Research

End Date: 28th February, 2015


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