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 : Senior Executive - QA
Roles and Responsibilities:
• Oversight for implementation of Site Quality procedures for inspecting, testing and controlling raw or packing materials and assessing in-process and finished product to ensure that all products conform to predetermined Pfizer Quality standards and Compendia Standards and Specifications. Provides or facilitates technical assistance to plant operations and third party customers.
• Monitors, audits and approves facilities and manufacturing operations for conformance with established procedures and requirements of the Pfizer and cGMPs. Provides interface between Pfizer and ZHOPL and facilitates investigation of product complaints and to improve customer service/product performance .
• Ensures maintenance of required records and documents, including tests results, inspections, file samples, supplier performance, product complaints, and product disposition, local and international regulations.
• Review and approval of Validation and Qualification protocols and reports as required
• Reviews and approves the change management requests as required and sits on change control committee.
• Supports response to field alerts, drug product recalls and returned drug products .
•Reviews and approval of significant non-conformances (Incidents, Deviations, OOS, and EIR etc.)
• Provides Quality support for Pfizer products and Supports GE (Geographic Expansion) projects as required.
• Supports technology transfers from other Pfizer R&D and manufacturing sites.
• Perform GAP assessment for site procedures with the Pfizer Quality standards.
• Responsible for developing and managing the Supplier Quality to support the Joint venture function.
• Responsible to liase with SMEs and key contacts from Pfizer centre and other Pfizer sites.
• Collaborating with different groups of Joint venture and other Pfizer sites as appropriate and needed to meet the company and business objectives.
• Responsible for taking sessions related to trainings on the Pfizer process, liasing with cross functional teams on projects etc.
Candidate Profile :
B.Pharm or M Pharrm in Microbiology / Quality assurance/ Chemistry
The ideal candidate should have excellent written and verbal communication, Strong inter personnel skills, proven ability to deliver outstanding results. Ability to multitask activities to meet the team Goals
Additional Information:
Location: Ahmedabad
Industry Type: Pharma
Last date: 30th November, 2016
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