4 Qms Knowledge Jobs

As a Microbiologist at Syngene Unit 3 Bangalore, your role involves being responsible for sterility testing, BET analysis, and ensuring the qualification and requalification of equipment in the Microbiology laboratory. Your core responsibilities also include initiating and closing OOS, Deviation, Change control, CAPA, and microbial data excursions, as well as participating in the preparation of SOPs and relevant documents. Additionally, you will be involved in analyzing raw materials, finished products, stability samples, and conducting various QCM related activities in the laboratory. Key Responsibilities: - Perform sterility testing using isolator - Conduct BET analysis using KTA/PTS - Qualification and requalification of equipment/instruments - Initiate and close OOS, Deviation, Change control, CAPA - Analyze raw materials, finished products, stability samples - Conduct QCM related activities such as sterilization, media preparation, growth promotion, culture maintenance, equipment calibration, etc. - Maintain microbiological trend data for the facility - Plan and schedule analytical activities in the department - Undertake any other tasks allocated by HOD or team leader Qualifications Required: - Experience: 6-10 years - Education: M.Sc in Microbiology or Biotechnology - Skills and Capabilities: Good knowledge of Microbiology skills and techniques, sterility testing, QMS knowledge, teamwork, communication skills About Syngene: Syngene is an innovation-led contract research, development, and manufacturing organization offering integrated scientific services from early discovery to commercial supply. Safety is a top priority at Syngene, with a focus on adherence to safe practices and procedures, driving a corporate culture that promotes environment, health, and safety mindset at the workplace. As an equal opportunity employer, Syngene values excellence, integrity, and professionalism in all its employees. Join Syngene to contribute to cutting-edge research and development in a dynamic and safety-focused work environment.,

We are looking for a meticulous Asst. Manager Production to lead production activities at Synnat Pharma Private Limited, ensuring seamless API manufacturing operations and adherence to the highest quality standards. As Asst. Manager Production, you will play a pivotal role in overseeing daily production activities, monitoring validation batches, and ensuring compliance with cGMP guidelines. Your responsibilities will include the preparation and review of production-related documents, coordination with cross-functional teams, and active participation in internal and external audits. You will also be responsible for identifying and resolving operational gaps, managing deviations and Out-of-Specification (OOS) incidents, and implementing Corrective and Preventive Actions (CAPA). With a strong focus on process optimization and continuous improvement, you will contribute to enhancing production efficiency and maintaining a facility that is always audit-ready. Your expertise in QMS (Quality Management Systems) and experience with ERP systems (SAP) will be crucial in driving operational excellence and ensuring the delivery of high-quality pharmaceutical products. Responsibilities: Oversee daily API production activities, ensuring compliance with established procedures and cGMP guidelines. Monitor validation batches, process parameters, and Batch Manufacturing Records (BMR/MBMR) for accuracy. Verify online BMRs and ensure compliance with regulatory and documentation standards. Coordinate with utility, QC, Stores, and Engineering teams to support seamless production operations. Supervise movement of finished products, intermediates, and recover solvents as per protocols. Identify and resolve operational gaps at the floor level to improve efficiency. Manage deviations, Out-of-Specification (OOS) incidents, and implement CAPA measures effectively. Ensure compliance with QMS and audit requirements; participate in internal and external audits. Prepare, review, and maintain accurate production documents, including validation protocols and training records. Develop preventive maintenance schedules, monthly production plans, and calculate raw material requirements. Train and mentor team members on production processes, compliance, and quality standards. Report production activities, deviations, and audit compliance to management while driving process improvements. General Expectations and Past Experiences: Strong understanding of API Manufacturing processes and cGMP guidelines. Demonstrated experience in preparing and reviewing production-related documents, including BMRs, validation protocols, and SOPs. Proven ability to manage and resolve deviations and Out-of-Specification (OOS) incidents effectively. Proficiency in using ERP Systems (SAP) for production planning, inventory management, and data analysis. Experience in participating in and contributing to successful internal and external audits. Strong leadership and communication skills with the ability to train and mentor production staff. In-depth knowledge of Cleaning Validation procedures and QMS (Quality Management Systems).

As a Quality Assurance Specialist at MacDermid Enthone Industrial Solutions, you will play a crucial role in maintaining all Management Systems smoothly, aiming for zero errors, eliminating customer complaints, and ensuring process control primarily onsite support for the Pune site. Your responsibilities will include establishing, implementing, and maintaining the Quality system in the organization according to International Standards ISO and IATF standards. You will also be responsible for controlling non-conforming products in coordination with Production and Quality Control, following up on statistical techniques, and ensuring QA-related activities such as change control process, NCPRR, internal corrective actions, and risk analysis. Additionally, you will handle customer audits, manage Supplier performance, assure quality control activities, conduct system adherence, manage process audits, and lead non-conformance closures. Training shop floor members on processes and quality maintenance will also be part of your role. To qualify for this position, you should have an MSc in chemistry or a Bachelor's degree in Chemical engineering with 2-4 years of relevant experience. A good understanding of Quality processes is essential for this role. Your competencies should include skills in quality assurance and testing, mandatory QMS knowledge, customer handling, and validation of processes. At MacDermid Enthone Industrial Solutions, we offer a conducive work environment that values Change Management, effective Communication, Customer Focus, and Individual Development. As an Equal Opportunity Employer, we encourage individuals who are self-motivated, energetic, self-aware, and willing to take ownership of continuous development to apply for this role and be part of our dynamic team.,

You should have a minimum of 10-12 years of experience in QMS knowledge, investigations, and report writing with a strong command of English writing skills. In the three decades of its existence, Piramal Group has pursued a twin strategy of both organic and inorganic growth. Driven by its core values, Piramal Group steadfastly pursues inclusive growth while adhering to ethical and values-driven practices. Piramal Pharma Solutions (PPS) is a Contract Development and Manufacturing Organization (CDMO) offering end-to-end development and manufacturing solutions across the drug life cycle. The team at PPS serves customers through a globally integrated network of facilities in North America, Europe, and Asia. Services offered include drug discovery solutions, process & pharmaceutical development services, clinical trial supplies, commercial supply of APIs, and finished dosage forms. PPS also provides specialized services such as the development and manufacture of highly potent APIs, antibody-drug conjugations, sterile fill/finish, peptide products & services, and potent solid oral drug products. Additionally, PPS offers development and manufacturing services for biologics including vaccines, gene therapies, and monoclonal antibodies, made possible through Piramal Pharma Limited's investment in Yapan Bio Private Limited. The track record of PPS as a trusted service provider with experience across varied technologies makes it a partner of choice for innovators and generic companies worldwide. Piramal Group is an equal employment opportunity employer. Employment decisions are based on merit, considering qualifications, skills, performance, and achievements to ensure equal opportunity in personnel matters for all applicants and employees, including recruitment, selection, training, placement, promotion, demotion, compensation and benefits, transfers, terminations, and working conditions. Reasonable accommodation is provided for qualified individuals with disabilities as well as individuals with needs related to their religious observance or practice.,