Head - QA & QC @ Navi Mumbai, India  Our client is a 100% export oriented Pharma company and they are looking for suitable candidates to fill the following position asap.  Position : Head - QA & QC  Education : B Pharm/MPharm/M Sc(Industrial/Analytical Chemistry)  Experience : 15 – 20 years of relevant experience in QA/QC function in reputed Indian/foreign MNC-Pharma Formulations Company. Experience in African market is desirable. Should have experience in WHO Geneva & PICS (Pharmaceutical inspection conference for harmonisation) audits...... MUST.  Location : Navi Mumbai ( Locals preferred )  Compensation : Competitive and commensurate with candidate caliber and experience  Role Responsibilities and Desired Profile :  1. Role is to lead and manage the Quality Department (QA&QC) across India operations. Develop and implement the Quality Systems of the Company for various sites & products. Plan and provide support to manufacturing activities as per Quality Management Systems (QMS) / GMP guidelines. Ensure the preparedness of system/ records for external inspections/audits from regulatory agencies/certifying agencies. Development of Quality Assurance systems for compliance of regulatory audits, continuous improvement with risk assessment and management. Technical investigations, assessment of non-conformances and its management by CAPA. Review change control requests and deviations and analyse quality impact. Design and implement validation master plan. Monitor adherence to cGMP / Pharamacopoeial requirements. Review and approve all documents for technology transfer and oversee execution of the process. Develop & monitor sample management system for control samples, validation samples, stability samples & market/customer samples.  2. Develop site master files and validation master plans of all sites. Identify training needs of quality teams; Conduct GMP, GLP and other training programs for employees across levels and functions. Provide strategic guidance to the teams which are responsible for dossier preparation / submissions, product approvals & registrations, compliance with policies and norms. Train & develop team capability for operation & trouble shooting for advanced analytical instruments like HPLC, GC, FTIR & UV etc. Handle the review & approval of specification for pharmaceutical ingredients and finished products; ensuring compliance with company standards. Supervise & review achievements as well as monitor team performance. Lead the quality audit process for new & existing - RM& PM vendors, contract manufacturing sites & third party sites.  3. Market complaints – Investigation, CAPA analysis, resolution of complaints & taking timely corrective action. Stability studies for all products (existing formulations & new formulations) as per FDA & internal guidelines and give feedback to the stakeholders. Establish effective plans, quality systems & procedures to assure compliance with all applicable regulatory bodies. He must possess good problem solving skills, good Inter personnel skills, communication and Excellent Managerial skills, good Analytical skills, good assertive skills.  If you fit in, please mail your CV in Word format alongwith current & expected CTC, notice period. Do mention exact job title in the subjectline of your mail for it to be noticed. We contact only shortlisted candidates.  Pradeep K. Sharma Founder CEO - PKS & Associates BC - 57, Nirvana Country, Sec - 50, Gurgaon - 122 018, INDIA http://www.linkedin.com/in/pradeepksharma

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Head - QA & QC - Pharma 

Head - QA & QC - Pharma  ,Job Description for Head - QA & QC - Pharma  in PKS & Associates in  Mumbai Others for (15-20) years of experience. Apply Now!

Job Description for Head - QA & QC - Pharma  in PKS & Associates in  Mumbai Others for (15-20) years of experience. Apply Now!