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 : Executive MQA
Job Description
MQ TS (Solution preparation-Vial/Ampoule collection and Tray loading) Specialist
MQ TS (Solution preparation-Vial/Ampoule collection and Tray loading) Specialist
Knowledge and Skills
Technical Skill Knowledge of
• Current regulatory expectation (India, FDA, EU. Compliance etc)
• In-process testing methods for sterile products, requirements for critical area maintenance, line clearance and other in-process QA requirements
• Experience in defending process in regulatory audits/inspection.
• Preferably experiences in good understanding of quality systems.
• Hands on experiences in manufacturing floor for sterile/ terminal sterilization operation.
Technical Skill Knowledge of
• Current regulatory expectation (India, FDA, EU. Compliance etc)
• In-process testing methods for sterile products, requirements for critical area maintenance, line clearance and other in-process QA requirements
• Experience in defending process in regulatory audits/inspection.
• Preferably experiences in good understanding of quality systems.
• Hands on experiences in manufacturing floor for sterile/ terminal sterilization operation.
Standards, Processes & Policies
• cGMPs and regulations governing manufacturing operations for sterile product
• Global Hospira quality policies and procedures
• cGMPs and regulations governing manufacturing operations for sterile product
• Global Hospira quality policies and procedures
Behavioral/ Any Other Skills
• Strong interpersonal skills
• Analytical thinking to grasp complex analytical issues and provide the feasible solutions
• Decision making on compliance of solution preparation to Vial/Ampoule collection and Tray loading activities to GMP procedures and Hospira global policies
• Ability to communicate effectively with all levels within the levels within the organization.
• Ability to role independently to completed activities are required
• Strong interpersonal skills
• Analytical thinking to grasp complex analytical issues and provide the feasible solutions
• Decision making on compliance of solution preparation to Vial/Ampoule collection and Tray loading activities to GMP procedures and Hospira global policies
• Ability to communicate effectively with all levels within the levels within the organization.
• Ability to role independently to completed activities are required
Candidate Profile
B.Pharm/M.Pharm / M.Sc ; Preferably 2+ years of experience in Manufacturing Quality /Quality Control/ Production or in Quality Assurance of a pharmaceutical manufacturing facility
B.Pharm/M.Pharm / M.Sc ; Preferably 2+ years of experience in Manufacturing Quality /Quality Control/ Production or in Quality Assurance of a pharmaceutical manufacturing facility
Additional Information:
Location: Vizag
Experience : 2+ years
Qualification : B.Pharm/M.Pharm / M.Sc
Industry Type: Pharma
Job ID: 4700923
End Date: 14th June, 2018
Location: Vizag
Experience : 2+ years
Qualification : B.Pharm/M.Pharm / M.Sc
Industry Type: Pharma
Job ID: 4700923
End Date: 14th June, 2018
Share:
0 comments:
Post a Comment