Job Title: Assistant Manager

Job Title Assistant Manager - Quality Assurance Chemistry Education Experience M Sc Industrial Chemistry B Pharma M Pharma having 8 to 10 years in API industry with related experience in the following fields QA Manufacturing GMP KEY ACCOUNTABILITIES 1 Quality Management Continuous Improvement Management and control of SOPs Master documents labels other GMP impacted documents Implementing necessary quality systems at the site including complaint Investigation qualification and validation change control deviation and non-compliance management documentation supplier quality assurance etc Out of specification Out of trend investigation Deviation Investigation Incidence investigation Review of Batch Manufacturing Records BMRs Analytical record related documentation Validation Qualification Change control review management Preparing the Annual Product Review and Annual Quality Review Batch Rework Reprocessing Approval Approval of repacking relabeling and non-standard batch size procedures as per applicable SOPs Release rejection API Intermediate Conducting training program Reviewing stability program Review of Analytical method validation and qualification documents of Analytical instruments Review of Equipment cleaning Records ECRs Issuance of all related GMP document ComplianceEnsure adherence to Corporate Quality Directives Local FDA regulations by Knowing the requirements Performing Gap analysis and making a compliance plan for closure of gaps Audit trail review Supporting Regulatory Affairs in related documentation Prepare for and attend to external regulatory quality audits Review of calibration and preventive maintenance program Review of work orders GMP round in plant Review of Stability Analytical documents Review of Audit Trail Validation Review of validation plans protocols and reports Review of qualification plans protocols and reports Documentation Control Preparations of quality system SOPs Review of other departmental SOPs To ensure controlled distribution and archival of documents and records Control changes in master documents and records through change control procedure Assuring quality of products by Ensuring compliance with applicable SOPs Management of deviation failure investigations By controlling the changes made to facility equipment product process and master documents and records by following change control procedure Investigation of customer complaints By ensuring implementation of corrective and preventive actions proposed in deviation failure investigations audit inspection compliance and customer complaint investigations Training To develop cGMP training modules and impart training Coordination QC Pharmaceuticals-Ankleshwar For testing of water for microbiological attributes environmental monitoring stability program local regulatory compliance HR A for training activity Purchase Mumbai and Ankleshwar For co-ordination of supplier QA activities IS - Ensure IS compliance in coordination with IS experts Other Coordinating with various agencies for making of the quality agreements Identifying and correcting unsafe conditions or behaviors and promptly reporting other potentially hazardous situations To support supplier quality assurance activity as needed Identifying and correcting unsafe conditions or behaviors and promptly reporting other potentially hazardous situations To conduct Third parties audit as per company requirement To execute any special task allocated by Manager REQUIREMENTS Technical skills Competencies LanguageKnowledge of GMP and regulatory requirements Good interpersonal team working and conflict management skills To handle complex situations with regulatory compliance Understands global organization and related processes Excellent communication skills Analytical technique