Quintiles looking for Quality Assurance Mgr

Quintiles is the world’s largest provider of biopharmaceutical development and commercial outsourcing services. We bring a fully integrated approach to build biopharma and life sciences solutions – from pipeline through portfolio to population health. A career with Quintiles connects you to great opportunity to achieve professional success and impact healthcare around the world.

Post: QA Mgr-1610844

Job Description
Purpose
Provide support to mgmt in the promotion and assessment of compliance with regulations, guidelines, and operating procedures. Manage QA oversight of projects, assignments, and training. Conduct independent audits to assess compliance with regulations, guidelines, and operating procedures. Prepare and distribute reports of findings to operations staff, management, and customers. Provide consultation in interpretation of regulations, guidelines, policies, and procedures.

RESPONSIBILITIES

1. Plan, schedule, conduct, report and close audit activities in any of the countries involved with Quintiles contracts. Audits are conducted to assess compliance with applicable regulations/guidelines, customer requirements, Quintiles SOPs and project specific guidelines/instructions. 
2.   Evaluate audit findings and prepare and distribute reports to operations staff, management, and customers.
3.  Provide interpretation and consultation to project teams on regulations, guidelines, compliance status, and policies and procedures. 
4. Provide consultation to customers, functional leads and monitors in interpretation of audit observations and formulation of corrective action plans. 
5. Prepare, review and approve corrective action plans 
6.  Present educational programs and provide guidance to operational staff on compliance procedures.  
7. Conduct quality assurance consultancy activities and projects for clients within budget and established timelines.
8.   Evaluate policies and procedures for compliance with applicable regulations/guidelines and provide recommendations to management for continuous process improvements.
9.   Host customer audits 
10.  Host mock regulatory inspections and regulatory facility inspections 
11.   Provide training for new Quality Assurance staff. 
12.  Serve as author of Quality Assurance SOPs as assigned. 
13. Advise Quality Assurance management on system audit needs. 
14.  Act as regional or Global QA Coordinator for assigned customers projects 
15.  Oversee documentation, reporting, and closure of compliance issues 
16. Lead Projects. 
17.  Train new auditors and staff as required.
18.   All responsibilities are essential job functions unless noted as nonessential (N).

Fine More Info On Next Page.....

Subscribe to Pharmatutor Job Alerts by Email

REQUIRED KNOWLEDGE, SKILLS AND ABILITIES 

• Knowledge of word-processing, spreadsheet, and database applications. 
• Extensive knowledge of pharmaceutical research and development processes and regulatory environments. 
• Considerable knowledge of quality assurance processes and procedures. 
•  Strong interpersonal skills. 
• Excellent problem solving, risk analysis and negotiation skills. 
• Exceptional training capabilities. 
• Effective organization, communication, team orientation, and leadership skills. 
•  Ability to work independently with initiative. 
•  Ability to manage multiple projects. 
• Ability to establish and maintain effective working relationships with coworkers, managers and clients  If you want to make an impact in the global research market, where we’re working to make a real difference in patient health, we ask you to apply now and join our team.   Qualifications

MINIMUM REQUIRED EDUCATION AND EXPERIENCE

•  Bachelor’s/primary degree 
•  7 years Quality Assurance experience in pharmaceutical, technical, or related area; or equivalent combination of  education, training and experience; or equivalent combination of education, training and experience

PHYSICAL REQUIREMENTS 

1. Position requires a significant amount of writing and keyboarding involving repetitive motions with fingers and sitting for  prolonged periods of time. 
2. Position requires extensive use of telephone and face-to-face communications, which requires the accurate perception of  speech. 
3.  Occasional travel.

Additional Information:
Qualification:   Bachelor’s/primary degree
Location: India
Industry Type: Pharma
Functional Area:  QA
End Date: 25th June, 2016

Apply Online>>

See All   B.Pharm Alerts    B.Sc Alerts    Chennai Alerts

See All   Other Jobs in our Database

PharmaTutor Magazine- Latest Issues

Subscribe to Pharmatutor Job Alerts by Email