4 Gxps Jobs

As the QA Head at Sun Pharma's Panoli location, you will be responsible for managing overall quality assurance oversight and site activities related to quality systems, including documentation review, SOP updates, in-process quality assurance, sampling and batch release, preventive maintenance/calibration/qualification/validation, internal audit, compliance, quality oversight of electronic systems, budget management, continuous improvement of quality systems, RA support, monitoring of pest control, and retention sample management in accordance with Good Manufacturing Practices requirements. You will ensure individual compliance with all regulatory requirements, GxPs, and applicable department programs. Your key responsibilities will include defining operational strategy and road map for quality assurance management at the site, setting quality assurance goals and strategy aligned with Sun Pharma compliance, product quality management objectives, and regulatory requirements, effectively managing site Quality Assurance activities and resources, providing strong leadership to ensure achievement of all Quality Assurance accountabilities, identifying and implementing solutions for improving existing quality assurance systems and processes, coaching and developing direct and indirect reports, managing site quality assurance revenue and capital budgets, ensuring availability of adequate resources to maintain compliance with GXP requirements, preparing the site for regulatory agency inspections/internal audits, and implementing corrective actions as needed. You will also be responsible for conducting Quality Management Reviews, monitoring individual performance, investigating market complaints, failures, and deviations, ensuring compliance with regulatory requirements on product, process, and release procedures, collaborating with all Sun Pharma sites, reviewing and tracking quality assurance metrics, managing supply chain management and vendor quality performance, providing inputs to manufacturing, R&D, and PDL work processes, designing/implementing quality related SOPs, policies, standards, and QA systems, facilitating audits, monitoring industry trends, fulfilling training requirements of quality assurance employees, ensuring compliance to computerized system standards, reviewing and approving documents, and working with cross-functional and corporate teams for new initiatives. The ideal candidate for this role should be a Science or Pharmacy Graduate Equivalent with a minimum of 15 years of experience, possessing knowledge of GxPs, cGMP, and other regulatory requirements, strong planning and prioritization skills, collaboration abilities, accountability, compliance orientation, customer service orientation, people connect, attention to detail, emotional control, effective communication, and problem-solving skills. Additional responsibilities may be assigned as required. The incumbent will work in both office and non-aseptic manufacturing/packaging environments, complying with gowning requirements for controlled areas and wearing personal protective equipment as needed. In the absence of the job holder, responsibilities will be delegated as follows: - Upward Delegation: Strategic site responsibilities to higher levels - Downward Delegation: Operational responsibilities to direct reports or similar job roles This job description provides a general overview of the responsibilities and requirements for the QA Head position at Sun Pharma, Panoli. The primary duties and responsibilities outlined are essential to the role, and additional tasks may be assigned as needed.,

Summary Of Responsibilities Works with internal teams to progress quality issues in QMS. Tracks timeliness of cases in QMS. Supports teams in creation of CAPAs. Maintains strong working knowledge of QMS. Interacts with QA Lead Manager and above as required for quality issue case progression and client notifications. Supports QA Lead Manager and above in pulling metric data, trending, and tracking of QI. All other duties as needed or assigned. Qualifications (Minimum Required) A minimum of a bachelors degree in Life Sciences preferred (or equivalent Life Science experience). Experience (Minimum Required) 8 years in regulatory environment (experience in GXP roles). Strong understanding of QMS and CAPA process. Ability to work well within a team environment. Convey key details of quality issues internally. Communicate quality issue summary to clients where applicable. Knowledge of GCPs/GXPs. Preferred Qualifications Include Fortrea may consider relevant and equivalent experience in lieu of educational requirements. Physical Demands/Work Environment Travel may be required. Office-Based (Hybrid), as requested by the line manager. Learn more about our EEO & Accommodations request here. Show more Show less

As the Microbiology Head at Sun Pharmaceutical Industries Ltd in Dewas, your primary responsibility will be to manage the overall site microbiology department. This includes overseeing sampling, testing, planning, qualifications, media fill program for sterile manufacturing, compliance, and upgrades of facilities and procedures. Your role will involve conducting effective reviews of the team and portfolio, providing direction and guidance to ensure product quality is maintained in adherence to GMP norms and timelines. You will be required to provide leadership and direction to achieve quality goals, organize timely microbiological sampling, testing, and release of raw materials, finished products, stability samples, water and utility samples, as well as environmental monitoring of various areas within the manufacturing blocks and warehouses. Additionally, you will be responsible for managing microbial cultures, laboratory investigations, and participating in internal, external, and regulatory inspections of microbiology operations. Ensuring compliance with GxPs, cGMPs, and safety standards in the microbiology laboratory is crucial, along with training microbiologists on techniques, aseptic practices, quality management skills, and personnel development. You will also be involved in preparing annual budgets for the microbiology section and liaising with the Corporate Micro team to implement microbial risk assessment programs. The ideal candidate for this position should be a Microbiology Graduate or equivalent with a minimum of 15 years of experience in microbiology work. Key success attributes include knowledge of regulatory requirements, compliance, collaboration, accountability, customer service orientation, planning, prioritization, attention to detail, people connect, emotional control, effective communication, and problem-solving skills. Additional responsibilities may be assigned as required.,

As the Section Head - Batch Release QA at Sun Pharmaceutical Industries Ltd, located in Halol (OSD), you will be responsible for overseeing IPQA activities and developing strategies in alignment with Sun Pharma Compliance, Product Quality Management objectives, and Regulatory requirements. Your role will involve planning and coordinating internal and external departmental support for quality assurance activities as per approved protocols and quality systems. You will be tasked with identifying and implementing solutions to enhance existing site quality assurance systems and processes, as well as managing batch release functions at the site. Your key responsibilities will include ensuring compliance with regulatory requirements related to products, processes, equipment, and release procedures, managing batch release activities for commercial dispatch, reviewing and approving investigations and CAPA, executing change control and risk assessment processes, and maintaining quality metrics reports as per specified timelines. You will also be responsible for coordinating with Quality Persons (QPs) and customers from different regions for batch release, managing technical agreements, overseeing warehouse and BSR operations, and handling retain sample storage, inspection, and life cycle management. To excel in this role, you are required to possess a minimum educational qualification of M.Sc/M.Pharm/B.Pharm along with at least 15 years of work experience. It is essential to have a strong knowledge of GxPs, cGMP, and other regulatory requirements, as well as demonstrate skills in planning, prioritization, collaboration, accountability, compliance, and customer service orientation. Additional attributes such as people connect, attention to detail, emotional control, effective communication, and problem-solving capabilities will be beneficial for your success in this position. In terms of the working environment, you will be working in both normal office settings and non-aseptic manufacturing/packaging environments. You should be prepared to work in areas with moderate to loud noise levels, comply with gowning requirements for controlled non-aseptic manufacturing areas, and wear personal protective equipment as necessary to ensure safety and compliance with GMP requirements.,