We have multiple vacancies in QC+QA based at Palghar for a a highly successful, fast growing, professionally managed, pharma manufacturing organisation. The organisation is very well funded, profitable and has multiple manufacturing units. It has a very wide product range covering capsules, tablets, creams, gels, injectables, lotions, powders, suspensions, solids etc. A major portion of their production is exported to a number of countries worldwide including to Regulated Markets and under USFDA norms. These vacancies have arisen as a result of the massive expansion plans of the organisation and hence the need to accelerate the QC & QA efforts. The organisation offers excellent work environment, salary+perks and career growth opportunities. The positions are expected to be closed on an urgent basis and inteviews will starts within next 7 days. Positions: 1. DGM / Plant Head QC: To continuously review quality control processes, procedures and capabilities in order to sustain the most cost effective and efficient methods for meeting quality requirements, and making recommendation for improvement as appropriate. Ensures compliance with the customer requirements, quality policy, company standards, regulatory and external standards. Validates quality processes by establishing product specifications and quality attributes; measuring production; documenting evidence; determining operational and performance qualification. Review and approve quality control documentation to ensure their planned activities meet requirements. Coordinates activities by scheduling work assignments, setting priorities, and directing the work of subordinate employees. Resource Management To coordinate and control the day to day operations of inspection personnel, so as to provide a safe, secure and efficient working environment, ensuring. All plant and equipment is safely operated. All physical resources are maintained, stored and organized to allow efficient and effective operation. To control and direct all QC resources, operations and facilities in order to adhere to project programmes. Identify staff development and training needs and ensures that training is obtained. Effectively interacts with Production and Engineering teams to maintain product supply and introduction of new products To manage and direct a team of skilled, semiskilled and technically based individuals through sound personnel practices. Compliance Manage and control all quality control activities in accordance with identified Quality Assurance standards, company procedures, specifications and requirements. Assist in production of generic and project specific Method Statements and Risk Assessments. Must have exposure towards all the major regulatory audits such as USFDA & UKMHRA. Management Information To monitor and report quality control progress, notifying any predicted shortfall or discrepancies against timescale and budgets. Immediate notification to the Head of Assurance of any Quality Control issues. Coordination and Liaison Contribute to Business Development and success of current projects by the internal referral and communication of appropriate information and intelligence, together with any project specific information. Provide comprehensive communication to underpin effective working relationships. Serves as a liaison with staff and management concerning error trends and problem areas. Candidate Profile: /B Pharm/M Pharm with min 15+ yrs of experience in the field of pharmaceutical Quality Assuarance. Good analytical skills, problem solving & decision-making. Proactive approach to problem solving, and relish the challenge of working in a fast moving company startup environment, as part of a highly interdisciplinary team. Should have knowledge of International & National regulatory guidelines regarding drugs. Should have GMP related training & experience. Ability to generate and control the team in areas of expansion. Must have first line exposure towards all the major regulatory audits such as USFDA, UKMHRA, EU GMP, PICs etc. Should have knowledge of handling software used in Pharma industry, such as SAP. Leadership and team working skills within own area and across the business. Commercial and financial awareness 2. DGM / Plant Head QA Job Description Exposure to overall quality system with QMS, Qualification, Validation & documentation. Lead of regulatory inspection, compiling insepectional responses and monitoring compliance for manufacturing facility Review and approval of cleaning validation policy & ensure its implementation. Review and release of batch processing records To ensure production operations are carried out in accordance with the good manufacturing practices and applicable regulations. To coordinate with other department for SOP review and ensure it implementation. Responsible for review and approval of technical agreement To ensure the awareness of cGMP requirements are evaluated and updated through periodic training and audits. To ensure market complaints are handled as per the SOP and proper investigation is performed with appropriate measures to prevent re occurrence. Good exposure into review change control, failure investigation and CAPA. Candidate Profile: MSc/B Pharm/M Pharm with min 15 yrs of experience in the field of pharmaceutical Quality Assuarance. Plant QA experience is compulsory. Should have knowledge of International & National regulatory guidelines regarding drugs. Should have GMP related training & experience. Should have fair knowledge of all sort of validation such as HVAC / water system / cleaning processes / Process / analytical methods / Computer system / Equipment and systems. Ability to generate and control the team in areas of expansion. Must have first line exposure towards all the major regulatory audits such as USFDA, UKMHRA, EU GMP, PICs etc. Should have knowledge of handling softwares used in Pharma industry, such as SAP, QMS softwares.