11 Capas Jobs

As a Quality Control Technician III at TAPI, you will be an integral part of the leading international supplier of active pharmaceutical ingredients (APIs). TAPI boasts the industry's broadest portfolio, which includes over 350 API products. With a rich history spanning over 80 years, we are recognized as one of the most trusted API suppliers globally, catering to 80 PERCENT of the top 50 pharmaceutical companies. At TAPI, our commitment to excellence is driven by our experience, expertise, cutting-edge technologies, and unwavering dedication to exceptional customer service. Your primary responsibilities will include maintaining 24/7 audit readiness, possessing expertise in Wet Chemistry, and being flexible to work in different shifts. You will actively participate in internal, external, and regulatory audits, ensuring full compliance with CAPA trainings. Additionally, you will be responsible for initiating and investigating LIR, OOS, OOT, and borderline results, promptly reporting them to the designated authority. Collaborating with various departments, you will facilitate the sharing of necessary documents from Quality Control to Regulatory Affairs and other relevant areas. In your role, you will play a crucial part in determining team priorities aligned with the plant's requirements, while coordinating effectively with team leaders and managers. Upholding stringent quality standards, you will adhere to housekeeping practices, cGMP, GLP, and Safety Guidelines within the laboratory. Your duties will encompass sampling and analyzing raw materials, finished goods, intermediates, and cleaning samples as per specific requirements, meticulously documenting results in analytical sheets, QA forms, LIMS, and online systems to ensure data integrity. Furthermore, you will conduct analytical tests following established monographs and SOPs, oversee the calibration and verification of instruments, and manage the reserved samples room along with chambers, autoclaves, and incubators. Your support will also be essential in preparing department-related documents such as STPs, SOPs, and more. Ensuring the timely sampling, approval, and rejection of labels for various products and maintaining accurate stock records of chemicals will be among your key responsibilities. To excel in this role, you should hold a Bachelor's or Master's degree in Chemistry and possess a minimum of 3 years of relevant experience in a similar capacity. Your dedication to upholding Teva's Equal Employment Opportunity commitment, which includes supporting diversity and providing equal opportunities to individuals with disabilities and veterans, is paramount in our inclusive work environment.,

Job Description Summary You will be delivering traceability, flow down of requirements to team, system design and analysis, requirements definition, Risk files, and Verification and Validation test procedures for NPI and install base (IB) products Owning & delivering the product investigations/CAPA/NC GE Healthcare is a leading global medical technology and digital solutions innovator Our mission is to improve lives in the moments that matter Unlock your ambition, turn ideas into world-changing realities, and join an organization where every voice makes a difference, and every difference builds a healthier world, GE HealthCare is a leading global medical technology and digital solutions innovator Our purpose is to create a world where healthcare has no limits Unlock your ambition, turn ideas into world-changing realities, and join an organization where every voice makes a difference, and every difference builds a healthier world, Job Description Roles and Responsibilities Owing and driving the Product Investigation & CAPA, Driving QMS process and owing the design control documents of the product, Participate in the domain technical and business discussions relative to product direction Support and contribute in the deliver the product scope Education Qualification Bachelor's degree in computer science or STEM Majors (Science, Technology, Engineering and Math), Technical Skillsets Minimum 8+ years in industrial experience and minimum 5+ years in system design or related experience, Experience in working Customer complaints, performing investigation, doing CAPAs, FMEA and documenting it (Mandatory) Knowledge in SDLC development process using Agile and QMS(Quality Management System) (Mandatory) Experience in creating engineering design artifacts like Requirement, Risk Files, Design document and other design control documents as per QMS process (Mandatory) Hands-on experience in Core Java, Spring boot, RESTful API's, RabbitMQ and Web Services Or Hands-on developing & executing level verification, Experience in collaborating with product development core team members (Engineering / QA / RA / Service / Leadership) , Proven ability to develop timely and effective solutions for challenging design problems, Experience developing system level requirements, customer flow-down requirements, System thinking and working in enterprise systems, Min 3+ years of engineering experience in a medical device field or Healthcare product, Experience Healthcare standards HL7/DICOM/IHE Business Acumen Demonstrates the initiative to explore alternate technology and approaches to solving problems Skilled in breaking down problems, documenting problem statements and estimating efforts, Demonstrates awareness about competitors and industry trends Has the ability to analyze impact of technology choices Leadership Ability to takes ownership of small and medium sized tasks and deliver while mentoring and helping team members Owing the NC/INVCAPA and deliver it independently (with less team support) Supporting & driving quality in the QMS design artifacts and product quality Providing guidance to team members on design artifacts and lead from front on Quality initiative, Providing status updates to leadership and collaborating with program NC/INV/CAPA stakeholders and drive to closure And demonstrate the effective communication skill Strong oral and written communication skills And Strong interpersonal skills Effective team building and problem-solving abilities Build product knowledge in more than one product Inclusion and Diversity GE Healthcare is an Equal Opportunity Employer where inclusion matters Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law, We expect all employees to live and breathe our behaviors: to act with humility and build trust; lead with transparency; deliver with focus, and drive ownership always with unyielding integrity, Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities Our salary and benefits are everything youd expect from an organization with global strength and scale, and youll be surrounded by career opportunities in a culture that fosters care, collaboration and support, #Everyroleisvital #Hybrid Additional Information Relocation Assistance Provided: No Show

As the Head of Corporate Quality in the Global Supply Organization at our base location in Navi Mumbai, India, you will play a crucial role in leading the development and execution of quality assurance strategies that are in line with our company's long-term objectives. Working closely with the Chief Technology Officer and the GSO Leadership Team, you will be responsible for ensuring the implementation of robust quality management systems, regulatory compliance, and driving continuous improvement in operational performance. Your responsibilities will include establishing best-in-class quality goals, analyzing quality metrics trends, implementing problem-solving strategies and system enhancements to achieve the desired levels of quality. You will lead and oversee the quality teams across all manufacturing facilities, focusing on continuous improvement initiatives. Team building will be a key aspect of your role, where you will be involved in establishing, inspiring, training, mentoring, and managing a team of QA professionals to adapt to new processes and tools effectively. Collaboration with business units to set quality targets for new and existing products, managing quality projects resulting from site consolidations or acquisitions, and working with the Quality Management System group to streamline and harmonize quality systems will also be part of your responsibilities. You will be responsible for maintaining the effectiveness of the Quality System across all Shalina manufacturing sites and Contract Manufacturing site, as well as implementing and monitoring an effective Vendor/Supplier development process. You will lead recruitment activities, ensure the professional development of direct reports and the overall company quality organization, and establish standards and metrics to support exponential growth while adhering to quality standards and regulatory guidelines. Additionally, your role will involve participating in various functional meetings, such as Supply Chain, Operational Excellence, and Sourcing, R&D. Your essential qualifications and experience include a degree in M.Pharm/B.Pharm/Master's in science, along with 15+ years of leadership experience in quality assurance, preferably in the pharmaceutical or life sciences industry. You should possess a strong understanding of ROW regulatory landscapes and international quality standards, exceptional commercial acumen, strategic business insight, and excellent consulting and communication skills to influence senior stakeholders effectively. Moreover, you should demonstrate personal credibility, strong interpersonal skills, integrity, dependability, and a results-oriented approach. Experience in working cross-culturally and cross-functionally with diverse colleagues is essential for this role. Your responsibilities will also include providing training efforts at Shalina sites as needed, advising and supporting alliance partners/service providers/central distribution center to ensure compliance with quality requirements, and offering immediate support during audits and compliance checks. In summary, as the Head of Corporate Quality, you will lead the development and execution of quality assurance strategies aligned with the company's goals, ensuring regulatory compliance, continuous improvement, and effective quality management systems across manufacturing facilities. Your role will involve team building, collaboration with business units, and maintaining compliance with global quality standards while supporting growth and customer satisfaction.,

As a quality control professional, you will be expected to strictly adhere to cGMP norms and safety rules within the factory premises. Your key responsibilities will include verifying logbooks, records, and other analytical documents on a daily basis to ensure their correctness and completeness. It will be your duty to ensure the timely preparation and revision of SOPs, STPs, and other Quality Management System (QMS) documents. You will also be responsible for the prompt completion of investigation activities related to Quality Control (QC) aspects such as Out-of-Specification (OOS), Out-of-Trend (OOT), deviations, and out-of-compliance (OOC) activities. Moreover, you will be accountable for the implementation of Corrective and Preventive Actions (CAPAs) as identified, ensuring their completion within the set timelines and evaluating their effectiveness. Additionally, you will prepare and revise calibration and preventive maintenance schedules as per the requirements of the facility. Your role will involve overseeing the calibration of instruments and equipment, both internally and externally, as per the defined schedule and maintaining proper documentation for the same. It will also be your responsibility to review audit trails for all application software used in the QC department to ensure sustained compliance with regulatory standards. Furthermore, you will review documents related to the qualification of working standards and reference standards, ensuring their accuracy. You will also be involved in the preparation and review of protocols for stability studies, instrument/equipment master lists, and quality risk assessments as needed. In the absence of the Deputy General Manager (DGM) or Deputy Chief Manager (DCM) of Quality Control, you may be required to deputize for them and undertake any specific tasks assigned by the Head of Quality. Your role is crucial in maintaining the quality standards and regulatory compliance within the organization.,

The role of Quality Control Manager in Critical Care Business at Bethlehem, PA involves overseeing all Quality Control functions to ensure alignment with core values and ethical practices. Your primary responsibility is to ensure that the Quality Control department meets the needs of both internal and external customers by delivering services and products on time. You will collaborate with various internal stakeholders such as API Manufacturing, Packaging, Quality Assurance, Engineering, Regulatory Affairs, EHS, Supply Chain and Logistics, as well as external stakeholders including Auditors, Customers, Regulatory Agencies, and External Suppliers. Reporting directly to the Senior Manager of Quality Control, your essential duties and responsibilities include leading a team of QC Analysts, ensuring compliance with quality systems and regulatory requirements, maintaining documentation, coordinating investigations and improvement projects, reviewing and approving test documents, managing quality processes through SAP system, overseeing batch production and testing, participating in product development support, and maintaining lab equipment. To be successful in this role, you must possess strong organizational and communication skills, critical thinking abilities, excellent customer service skills, creativity in problem-solving, energetic and motivational disposition, confidentiality maintenance, coaching skills, proficiency in computer tools, and the ability to lead a team in a fast-paced environment while managing multiple projects effectively. The ideal candidate should have a B.S. in Chemistry or a related discipline, minimum 5 years of experience in a pharmaceutical manufacturing laboratory environment, at least 3 years of supervisory experience, hands-on experience with quality systems in a GxP environment, familiarity with FDA, MHRA, and other health authority inspections, knowledge of international regulations, and audit experience. If you are looking for a challenging opportunity in Quality Control with a focus on pharmaceutical manufacturing, this role at 3950 Schelden Circle, Bethlehem, PA, 18017, US might be the perfect fit for you.,

The Quality Assurance (QA) Executive API (Bulk Drugs) role based in Savli, Gujarat requires a candidate with 2-5 years of experience and a qualification of B.Sc / M.Sc. As a QA Executive, your responsibilities will involve ensuring compliance with cGMP, ICH, and regulatory guidelines in API (bulk drug) manufacturing. You will be responsible for preparing, reviewing, and controlling SOPs, BMRs, BPRs, change controls, deviations, and CAPAs. In addition, conducting in-process checks for manufacturing and packaging activities, handling investigations for deviations, OOS/OOT results, and supporting root cause analysis are key components of this role. You will also be involved in participating in internal audits, regulatory audits (USFDA, EU, WHO, etc.), and vendor audits. Maintaining documentation for batch release, validation protocols, and quality systems, ensuring adherence to data integrity and good documentation practices (GDP), and supporting qualification and validation activities are crucial aspects of this position. Collaboration with cross-functional teams such as Production, QC, and R&D is essential for ensuring smooth operations. This is a full-time, permanent position with benefits including health insurance and Provident Fund. The work schedule is day shift with additional perks such as performance bonus and yearly bonus. The work location is in person.,

As a Security leader with a background in AWS and cloud Security, you play a crucial role in defining and enforcing the security policies and procedures of the organization. With excellent written and verbal communication skills, exceptional organizational abilities, and expert-level proficiency in IT and Cloud Security, you will be responsible for architecting and implementing IT Security policies while reporting to the Director of Information Technology. In this full-time role, your essential duties and responsibilities include providing leadership and technology vision to the IT Security team, performing internal and external security audits, documenting, implementing, and monitoring adherence to IT security standards, as well as assessing and improving security metrics. You will work on enhancing security tools and operations, monitor and manage IDS, vulnerability scanning, and assessments, and serve as the Data Privacy Officer (DPO) for the company. Creating awareness within the company regarding Security, Privacy, and compliance requirements, ensuring security and privacy training for staff involved in data processing, conducting security and privacy audits, and serving as the point of contact between the company and clients for privacy controls are key aspects of your role. Additionally, you will be responsible for log aggregation and analysis, managing Anti-Virus software, addressing security and data breach-related incidents, and ensuring customer satisfaction while being accountable for individual product/project success and quality. To qualify for this position, you must hold certifications such as CISSP, Security+, or equivalent, along with having 10+ years of Cyber Security experience, 5+ years of IT management experience, 5+ years of AWS experience, and 3+ years of experience with Identity & Access Management tools. Your extensive experience with Linux & Windows Security administration, managing Cloud and Container Security, Network and Application penetration testing, vulnerability scanners, IDS, IPS deployment and monitoring, SIEM tools, security automation, incident response & management, vulnerability management, and patch management will be essential. Moreover, your role will involve ensuring organization efficiencies through continual improvement programs, representing the organization in inspections and audits, driving action plans to closure, conducting deep dive RCAs and ensuring CAPAs are closed, and maintaining a metrics-driven approach. Additional qualifications such as experience with monitoring tools like Datadog, Change Management, Configuration Management, Infrastructure as Code tools, hardening Operating Systems and Applications, endpoint security management, working in GxP environments, and familiarity with various practices will be beneficial. With no travel expectations, this role requires a dedicated and experienced professional who can effectively lead security operations and teams, prioritize security and privacy, and drive continuous improvement initiatives to enhance organizational security posture.,

Oversee all QA activities related to API manufacturing in line with cGMP and regulatory standards. Review and approve manufacturing and analytical documents including MBMRs, BPRs, validation protocols and reports.

Ensure compliance with cGMP, ICH, and regulatory guidelines in API manufacturing Review and approval of master batch manufacturing records (MBMR) and batch packing records (BPR).

Regulatory Strategy & Compliance – US FDA, EU MDR, CDSCO Documentation & Regulatory Submissions Regulatory Monitoring & Reporting UDI Submission – GUDID / EUDAMED Regulatory Audits, Inspections, CAPAs & NCs Closure Required Candidate profile BE/BTech in Mechanical, Biomedical, Biotech, or related fields Min 2 years of exp. in RA for medical devices Knowledge of U.S. FDA, EU MDR, CDSCO regulations RAC/GATE certification is a plus

Job title manager GMP (Good Manufacturing Practices) QA (Quality Assurance) Reports to Head of Quality Assurance (GMP and GCP) Job purpose Our Quality team is growing, and we are currently seeking a Manager of GMP QA Operations to play a pivotal role in ensuring the quality and compliance of our clinical and commercial manufacturing processes. Reporting to the Head of QA, the Manager will oversee a team responsible for manufacturing, batch record release, investigations, deviations, CAPAs (Corrective and Preventive Actions), change controls, analytical methods, stability programs, and auditing within our GMP operations. Duties and responsibilities QA managers define and implement quality standards for products or services. Author or review Ocugen quality standards, procedures, and work instructions. Participate in cross - functional teams to establish and enhance the quality systems and support for managing high levels of quality compliance at contract manufacturers. Build strategic relationships with CDMOs (Contract Development and Manufacturing Organization) within the Quality organization and participate in Business Review Meetings to ensure Quality issues are identified, managed, addressed, and escalated, as necessary. Establish, maintain , and monitor supplier files including Quality Agreements with CDMOs and directly related suppliers to the CDMOs. Responsible for the quality review and approval of master batch records, executed batch records, reports, protocols, analytical methods, change controls, investigations, OOS (Out of Specifications), OOT (Out of Trends), deviations, and CAPA for development, clinical and commercial processes, assess impact and provide quality oversight of implementation activities. Support RCA (Root Cause Analysis and associated tools) and product impact assessments for investigations resulting from deviations and OOS events. Oversee, review, and approve quality testing processes and identify gaps in testing. Oversee, review, and approve manufacturing processes and identify gaps in manufacturing. Overseeing, reviewing, and approving quality events and ensuring effectiveness is part of business improvements. Staying up to date with relevant laws and regulations to ensure compliance. Train other employees in quality standards and procedures and handle quality reports, documentation, and records. Collect and analyze QA data and prepare monthly and quarterly metrics regularly. Work with GMP vendors to ensure their quality and conduct vendor audit if necessary. Participate in internal audit program and followup on CAPA (Corrective and Preventive Actions) assigned to closure within the timeframe. Eliminating products that are not up to standards and finding the reasons for product problems Identify potential risks before they become a problem, focusing on root cause analysis and preventive action Identify opportunities for process improvements and efficiencies within the QA Operations function, driving continuous improvement initiatives. Qualifications: Bachelor' or Masters in Biology, Chemistry, or related fields. At least eight (8) years for BS and five (5) years for MS GMP experience with a focus on quality with substantial operational and GMP experience supporting Biologics/Vaccines/Cell and gene therapy products. At least five (5) years in roles of increasing management responsibility in a biopharmaceutical environment; at least two (2) years managing Phase 1-3 clinical trials. Prior experience and a broad range of knowledge in Quality, Compliance, or a combination of experience such as Manufacturing, Quality, and Regulatory required. In-depth knowledge of the international regulatory landscape is preferred. In-depth knowledge of and ability to interpret and apply GMP EU, FDA (Food and Drug Administration), USP (United States Pharmacopeia), Phr. Eu., WHO, PMDA, and ICH regulations and guidelines. Excellent written, verbal, listening, and interpersonal communication skills. Ability to professionally interface with all levels (e.g., senior-level executives, staff, colleagues, external partners, consultants, and contractors). Integrated Quality leader who can build strong collegial relationships cross-departmentally while effectively and courageously driving regulatory compliance. Ability to manage multiple and sometimes conflicting priorities in a fast-paced and demanding environment. Proven background in GxP and GMP audit management, risk management, mitigation, and controls. Proficient in Veeva Vault systems (QualityDocs, Training, eQMS, RIM, etc.). Working conditions This position operates primarily in an office setting and may include 10% of travel. This position is in Hyderabad, INDIA (on-site). This position will work in US business hours. Physical requirements This is a sedentary role.