Work for Masters Degree in Science as Manager, Quality Operations in Pfizer..."R"

Work for Masters Degree in Science as Manager, Quality Operations in Pfizer

Founded in 1849, Pfizer is the world's premier biopharmaceutical company taking new approaches to better health. We discover, develop, manufacture and deliver quality, safe and effective prescription medicines to treat and help prevent disease for both people and animals. We also partner with healthcare providers, governments and local communities around the world to expand access to our medicines and to provide better quality health care and health system support. At Pfizer, colleagues in more than 90 countries work every day to help people stay happier and healthier longer and to reduce the human and economic burden of disease worldwide.

Post: Manager, Quality Operations

Responsibilities:
- Provide leadership to Quality Assurance and Quality Control function
- Closely interact with departmental heads and active member of PGS Management Team.
- GMP / Technical Audit function at site / off-site.
- Close monitoring of Deviations / OOS./ Change Controls, Stability Programme,
- Product complaint handling
- Dealing with local FDA
- Demonstrates leadership, management and technical capabilities and is an active change agent
- Ensures establishment, implementation and adherence to quality pharmaceutical manufacturing standards

Job Description:
- Technical support to Off-Site manufacturers
- Co-ordination with Off-Site manufacturers for monitoring product quality
- Audits of Off-Site manufacturers and vendors. Evaluate and recommend necessary improvements in the system.
- Support Head , Quality for overall quality function
- Handling of Product complaints
- Responsible for adoption and compliance with ICH and local regulatory requirements.
- Evaluate and improve upon existing methods and testing techniques; evaluate the use of new analytical methods, improved GLP/EHS practices.
- Actively participate and support the product development group for new products and existing products.
- To update documents for sustaining and enhancing quality standards.
- Review of Dossiers

Job Specification
1. Qualification
- Minimum Masters Degree in Science.
- Minimum 10  -15 years experience in the Pharma industry in Quality function
- Experience of working in cross-functional teams and providing leadership

.  Special Skills & Knowledge
- Strong knowledge in Pharmaceutical dosage forms, processes and technologies.
- Demonstrated leadership, management and technical capabilities
- Knowledge of GMP and Quality Systems.
- Deep knowledge of Drugs and Cosmetics Act, ICH  guidelines, Method Development
- Knowledge of GLP, Instrumentation and analysis
- Knowledge of relevant Computer Systems
- Strong verbal, written and interpersonal communication skills
- Demonstrated success interacting with regulators

3. Key Competencies
- Interact with peers and superiors on regular basis
- Good Auditing and Documentation Skills
- Analytical Thinking
- Flexibility , Change Management
- Building expertise
- Concern for quality
- Developing people
- Planning and Prioritizing
- Initiative

Additional Information
Experience: 10-15 Years
Job ID: 988710
Functional Area: QA/QC
Location: Thane
Last Date: 20^th Dec. 2013