Job Description
Provide support to management in the promotion and assessment of compliance with regulations, guidelines, and operating procedures. Manage the quality assurance oversight of projects, assignments, training and staff. Conduct independent audits to assess compliance with regulations, guidelines, and operating procedures. Prepare and distribute reports of findings to operations staff, management, and customers. Manage the investigations of quality issues, customer audits and regulatory inspections. Provide consultation in interpretation of regulations, guidelines, policies, and procedures. Establish and maintain relationships with internal customers such as Project Unit, Operational and Regional Heads and their management teams and external customer Quality Assurance (QA) functions. Act as line manager for one or more QA staff.
Provide support to management in the promotion and assessment of compliance with regulations, guidelines, and operating procedures. Manage the quality assurance oversight of projects, assignments, training and staff. Conduct independent audits to assess compliance with regulations, guidelines, and operating procedures. Prepare and distribute reports of findings to operations staff, management, and customers. Manage the investigations of quality issues, customer audits and regulatory inspections. Provide consultation in interpretation of regulations, guidelines, policies, and procedures. Establish and maintain relationships with internal customers such as Project Unit, Operational and Regional Heads and their management teams and external customer Quality Assurance (QA) functions. Act as line manager for one or more QA staff.
Candidate Profile
* An excellent knowledge of current GXP regulations and guidelines, and associated regulatory requirement.
* 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.
* Effective organization, communication, team orientation, and leadership skills.
* Ability to work independently with initiative.
* Ability to manage multiple projects.
* Ability to manage staff
* Strong training capabilities.
* Ability to establish and maintain effective working relationships with coworkers, managers and clients
* An excellent knowledge of current GXP regulations and guidelines, and associated regulatory requirement.
* 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.
* Effective organization, communication, team orientation, and leadership skills.
* Ability to work independently with initiative.
* Ability to manage multiple projects.
* Ability to manage staff
* Strong training capabilities.
* Ability to establish and maintain effective working relationships with coworkers, managers and clients
Qualifications
* Bachelor’s/primary degree
* 7 years Quality Assurance experience in pharmaceutical, technical, or related area, including GCP Quality Assurance experience; 5 years of management experience; or equivalent combination of education, training and experience; or equivalent combination of education, training and experience
* Bachelor’s/primary degree
* 7 years Quality Assurance experience in pharmaceutical, technical, or related area, including GCP Quality Assurance experience; 5 years of management experience; or equivalent combination of education, training and experience; or equivalent combination of education, training and experience
Additional Information:
Experience: 7 year
Location: India
End Date: 22nd April, 2014
Experience: 7 year
Location: India
End Date: 22nd April, 2014
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