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Work as QA Manager in Quintiles

 

Clinical courses

Quintiles is the only fully integrated biopharmaceutical services company offering clinical, commercial, consulting and capital solutions worldwide. Our network of 23,000 engaged professionals in 60 countries around the globe works with an unwavering commitment to patients, safety and ethics — ensuring a higher level of healthcare for people. For our biopharmaceutical customers, we help them navigate risk and seize opportunities in an environment where change is constant.
Quintiles is consistently cited as the most favored contract research organization (CRO) in independent surveys of the bio pharma industry and was recently named “2009 CRO of the Year” by the prestigious SCRIP Awards.

Post: QA Mgr-1506256

Job Description
PURPOSE
• Facilitate RCA and conduct multifaceted investigations on critical quality issues and findings, assuring resulting corrective and preventative actions are appropriate, enacted and evaluated for effectiveness.
• Prepare and conduct annual FMEA activities on specified core processes.
• Ensure the timely reporting of these activities to management via the electronic reporting systems.

RESPONSIBILITIES
• Support QA Leads and stakeholders by facilitating RCA activities on critical issues and findings.
• As part of RCA activity and where appropriate (for example for emerging issues) provide rapid response resource to plan, conduct and report multifaceted investigations, occasionally globally.
• Where relevant, use BPO, Lean/Six Sigma and/or Black Belt processes to conduct investigations.
• Ensure the timely reporting of all RCA, investigation, FMEA and associated activities in the electronic reporting systems
• Evaluate resultant CAPAs for probability of success and evaluate for effectiveness.
• Ensure any lessons learned from investigations are appropriately captured and processed by the relevant teams as necessary.
• Prepare and conduct FMEA activities on specified core processes as part of the annual process robustness assessment.
• Driving continuous improvement of investigation processes, training and supporting tools
• Present educational programs and provide guidance/consultancy on BPO, Lean/Six Sigma and/or Black Belt processes to Customers, QA and Operations
• Evaluate policies and procedures for compatibility with lean/six sigma principles, where required.
• Provide RCA and/or investigation training as required.
• Assist in the training of new RRT staff


REQUIRED KNOWLEDGE, SKILLS AND ABILITIES
• Extensive knowledge and experience in the application of BPO, Lean/Six Sigma, and/or Black Belt processes in a pharmaceutical and/or development environment.
• Excellent problem solving, risk analysis and negotiation skills.
• Excellent ability to initiate tasks and to work independently.
• Knowledge of pharmaceutical research and development processes and regulatory environments.
• Knowledge of quality assurance processes and procedures.
• Excellent verbal and written English
• Ability to establish and maintain effective working relationships with co-workers, managers and customers
• Ability to manage multiple projects
• Strong interpersonal skills.
• Strong organization, communication, and team orientation skills.
• Good training capabilities.

Candidate Profile
MINIMUM REQUIRED EDUCATION AND EXPERIENCE
• Bachelor’s/primary degree in Science or Engineering
• 5 years experience in pharmaceutical, technical, or related area, of which 3 years in the practical application of processes such as :
- BPO
- Lean/Six Sigma black belt
- FMEAs
- Familiarity with other process optimisation techniques or equivalent combination of education, training and experience


Additional Information:
Experience: 5 years
Location: India
Education: B.Sc, BE
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: QA
End Date: 15th May, 2015

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