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: Manager Quality Assurance
Job Description:
The Incumbent is the head of the Quality assurance function reporting to the Lead Quality Operations at the plant accountable for ensuring that QA activities are carried out in a manner compliant with Corporate policies, Plant SOPs, cGMP, GLP ,and all applicable FDA regulations.
Responsible and authorized to release or reject or hold all components, drug product containers, closures, in process materials, packaging material, bulk materials, finished products, labeling, drug products, reworked and reprocessed materials.
To evaluate executed batch manufacturing records to assure that all necessary testing is carried out, no errors have occurred or, if errors have occurred, that they have been fully investigated.
To review and recommend approval for all procedures, Master Batch records, specifications, artworks of packaging material, sampling plans, test methods, Validation documentation, Product manual, Master formula records, Master training plan, training curricula’s, Annual product reviews Calibration and preventive maintenance schedules, training outlines, site master file that relate to GMP and product quality.
To conduct vendor audits and recommend for approval of vendor list.
To review all Change Controls.
To prepare Quality agreements in consultation with QO Lead and legal department.
To ensure that an effective system for the investigation and resolution of deviations and out of specification results applicable to laboratory and manufacturing operations is established, implemented and maintained.
To ensure an effective stability program is established and maintained.
To ensure a program for product complaints and complaint handling is established and maintained.
To ensure implementation of system on Annual product reviews.
To ensure an effective Quality audit program is established and maintained.
To ensure a system for prompt notification to management and regulatory agencies is established and maintained.
To ensure implementation of effective Recall/Product withdrawal program.
To ensure a system for review and approval of GMP related regulatory submission components is established and maintained.
To ensure an effective system to review and approve changes that might impact product quality is established and maintained.
To ensure system on periodic calibration and preventive maintenance is established and maintained.
Liaison and follow up with Regulatory authorities( local FDA/WHO/Central Drug Controller) for Regulatory submissions, renewal/ amendment of product/manufacturing licenses and GMP certificate.
To organize and conduct Monthly/quarterly Plant Quality Council meeting, prepares/circulates agendas and minutes.
To conduct training on departmental procedures.
To collate and submit data for IMR metrics to IMR Co-coordinator.
ALL INTERNAL CANDIDATES MUST CONSULT THEIR MANAGER PRIOR TO THE APPLICATION
Job Id: 961740
Location: GOA
Last Date to Apply For Job: 17 March, 2012
TO APPLY CLICK HERE AND PUT JOB ID.
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