Note: We are looking for Quality Assurance Head to manage one of the API unit. Those who are already in similar position are eligible to apply Client : Leading pharma company Role : Quality Assurance Head (API Unit) Location: Vishkhapatnam/Vizag Qualification : Bachelor/Masters degree in Pharmacy or Chemical Engineering or Masters in Organic Chemistry Experience: 18-20+ years of experience in Pharmaceutical / Chemical industry in Quality Management and Manufacturing Operations. CTC : 38-40 LPA (all inclusive) Candidate should be stable in companies. Frequent job changes will not be entertained Mandatory skills: - Experience in leading Regulatory Inspections (e.g. FDA, EU) is a must. - Strong Knowledge of GMPs (ICH Q7 and 21 CFR 210/211,) and other regulatory guidelines like ICHQ1-Q4, QMS, SUPAC, etc. - Strong leadership and interpersonal skills. - Excellent written and verbal communication skills. Responsibilities : - Responsible for all quality assurance operations of API site located at Visakhapatnam - To ensure that Quality systems and Procedures are followed as per the Company's Policy with a complete focus on compliance activities at sites - To ensure all activities associated with manufacture and testing of the medicinal product have been conducted in accordance with the principle and guidance of GMP. - To make sure that quality, GLP, GDP and safety practices implementation. - To ensure the compliance with 21 CFR Part-11 requirements for electronic systems. - To lead the teams in meeting the deliverables and escalate the critical issues to reporting authority for action plan. 7.To ensure the investigations adequacy related to deviation, OOS, OOT, market complaints and any other noncompliance as required and associated CAPA plans. - Auditing, reviewing and/or approving vendors & analytical labs based on requirement. - Ensuring the changes that potentially impact Intermediate or API quality. - Support to Regulatory/ Customers/Internal/External for Quality and filings, etc. - Evaluation of critical and major QMS elements like Change control, Deviation, Risk assessment, CAPA, Process qualification / Validation protocols/Reports, etc. - Support to site QA for all testing and release of raw material, packing material, in-process finished products and stability program as per the written procedures. - To ensure that the required initial and continuing training of department personnel is carried out and adapted according to need. - Responsible to identify the SOP needs and implementation in all API sites. - Responsible for approval CQA related QMS activities (Complaints, Deviations, CAPA etc) either manually or in software applications. - Participation in management reviews of process performance, product quality and quality management system and advocating continual improvement. - Ensuring that a timely and effective communication and escalation process exists to raise quality issues to the appropriate levels of management. - To ensure and approve Risk Assessment as appropriate that strengthen the quality decision, understanding the risk associated as part of impact assessment. - To handle the entire Quality aspects. Quality Harmonization, Quality inspection & monitoring at respective location and quality improvement program. - Review and approval of quality agreements. Handling of product recalls and return goods. - Handling of various regulatory/customer audits including local drug control authority audits and compliance report for the observations reported during audits. - To ensure execution of internal audits as per pre-approved schedule. - To monitor the breach of data integrity and provides support to develop control and measures to improve the data integrity Those interested please contact Manisha 9873002499

Vishakhapatnam/Vizag

Head - Quality Assurance - Pharma - API Site Unit 

Head - Quality Assurance - Pharma - API Site Unit  ,Job Description for Head - Quality Assurance - Pharma - API Site Unit  in ABP Management Services in  Vishakhapatnam/Vizag for (18-26) years of experience. Apply Now!

Job Description for Head - Quality Assurance - Pharma - API Site Unit  in ABP Management Services in  Vishakhapatnam/Vizag for (18-26) years of experience. Apply Now!