2 Packaging Validation Jobs

Role & responsibi The Head of QA/QC will be responsible for establishing, implementing, and maintaining quality management systems across the cosmetics manufacturing value chain. This role ensures that all products meet regulatory, customer, and company standards for safety, efficacy, and consistency. The incumbent will lead both Quality Assurance (QA) and Quality Control (QC) teams to achieve compliance with cGMP, ISO, and cosmetic industry regulations. lities Key Responsibilities Quality Assurance (QA): Develop, implement, and maintain Quality Management Systems (QMS) aligned with cosmetic industry standards (ISO 22716, GMP, FDA, BIS, EU Cosmetics Regulations, etc.). Establish and monitor SOPs for production, packaging, warehousing, and distribution processes. Oversee validation and qualification activities (equipment, process, cleaning, method validation). Drive regulatory compliance audits and ensure timely closure of CAPA (Corrective and Preventive Actions). Manage risk assessments, deviation handling, OOS (Out of Specification) investigations, and ensure continuous improvement. Ensure compliance with product safety, labeling, and claims regulations in domestic and international markets. Quality Control (QC): Supervise incoming raw material, packaging material, in-process, and finished product testing (physical, chemical, microbiological). Establish and monitor specifications, testing protocols, and acceptance criteria for all products. Oversee calibration, maintenance, and qualification of laboratory equipment. Ensure timely release of raw materials and finished products as per quality standards. Review and approve analytical test results, COAs, and stability studies. Leadership & Strategic Functions: Lead, mentor, and develop the QA/QC team; build a culture of accountability and excellence. Liaise with regulatory bodies, certification agencies, and third-party auditors. Collaborate with R&D, Production, Supply Chain, and Marketing teams to ensure smooth product lifecycle management. Drive continuous improvement projects (Six Sigma, Lean, Kaizen) in quality operations. Provide strategic inputs to management for product recalls, market complaints, and regulatory updates. Key Skills & Competencies Strong knowledge of cosmetic GMP (ISO 22716), FDA guidelines, BIS standards, and international regulations (EU, ASEAN, GCC, etc.). Expertise in formulation, stability testing, microbiology, and packaging validation. Proficiency in quality tools and systems QMS, CAPA, RCA, FMEA, Risk Management. Strong analytical, decision-making, and problem-solving skills. Leadership skills with the ability to manage cross-functional teams. Excellent communication, documentation, and audit management skills. Qualifications & Experience Education: M.Pharm / B.Pharm / M.Sc. (Chemistry, Microbiology, Biotechnology, Cosmetic Science, or related field). Experience: Minimum 5+ years of experience in Quality (QA/QC) within the cosmetics, personal care, FMCG, or pharmaceutical industry, with at least 5+ years in a leadership role. Experience in handling regulatory inspections and certifications. Preferred candidate profile

Azurity Pharmaceuticals is a privately held, specialty pharmaceutical company dedicated to developing innovative products to serve underserved patients. With a focus on providing unique, accessible, and high-quality medications, Azurity continuously expands its commercial product portfolio and late-stage pipeline by leveraging integrated capabilities and a vast partner network. The company's patient-centric offerings span various markets including cardiovascular, neurology, endocrinology, gastro-intestinal, institutional, and orphan markets, positively impacting millions of patients. As an inclusive workplace and Equal Opportunity Employer, Azurity attributes its success to a team of talented individuals committed to enhancing patient lives through a combination of cutting-edge science and unwavering dedication to quality. The company values highly motivated individuals with integrity, dedication, and creativity to thrive within its organization. The Technical Operations department at Azurity is responsible for overseeing technical process strategy, managing contract manufacturing organizations (CMOs) and contract development and manufacturing organizations (CDMOs), and delivering product objectives in line with company policies and client requirements. This role involves leading teams, collaborating cross-functionally, and achieving project milestones to support process scale-ups, validation, technical transfers, post-approval changes, and investigations for commercial products. **Principal Responsibilities:** - Manage the planning and execution of manufacturing activities, including qualification and validation for both development and commercial products. - Coordinate with contract facilities to review, approve, and execute controlled documentation related to late-stage development, qualification, validation, and manufacturing activities. - Direct tasks associated with late-stage product/process development, product transfers, equipment qualifications, and validation to ensure alignment with company objectives. - Support or lead product launch and commercialization efforts. - Establish and maintain policies, SOPs, and documentation to support validation practices per regulatory requirements and industry guidance. - Assist in Management Review and Compliance activities, preparing metrics and summaries for senior management communication. - Support Due Diligence activities related to product development, technical transfer, manufacturing, and commercial launch. - Collaborate with cross-functional team members from Supply Chain, Product Development, Quality Assurance, and Regulatory Affairs. **Qualifications And Education Requirements:** - Bachelor's degree in Life Sciences (Master's degree preferred) or related field. - Minimum 15 years of experience in biopharmaceutical/pharmaceutical GMP environment or related industry. - Expertise in cGMPs, ICH, and Validation related requirements. - Proficiency in technical transfer of multiple dosage forms, various validation disciplines, and regulatory agency inspections. - Ability to work strategically, tactically, and hands-on. - Proficient in Microsoft Word, Excel, and Powerpoint. By applying for this role, you confirm your capability to fulfill the job responsibilities outlined in the job description without any restrictions. If you have any concerns or disabilities that may impact your ability to perform the job, please inform HR in advance.,