Quality & Compliance Role - Pharma/OTC Products (4-7 yrs)

Job Description

Individual Contributor || Quality and Compliance || Pharma and OTC Products- Deep knowledge of product compliance, quality & regulatory requirements with a focus on product- Responsible for proactive and preventive quality assurance and control, delivering end to end result throughQMS activities :- Factory elevation through technical support to drive for continuous improvement of manufacturing processes.- Ensure vendors deliver safe and quality owned brand product.- Leverage analysis and reporting on vendors & factories performance with a feedback loop.- Actively influence decision-making and address business needs through active engagement with CFT/business partners.- Conduct calibration activities on process and product for 3rd parties, vendors and factoriesKey Competency Expectation :- Product and Technical knowledge- Category level product knowledge; understand the guest expectation/brand expression through product standards, specification, approved samples and testing requirement/protocols to support field operations- Ensure the products are good & healthy, safe to use, guest friendly and durable & functional through product lifecycle- Knowledge of product and manufacturing process risk assessment and mitigation to support product development - Identify and validate key quality and capability callouts (e.g., manufacturing variability,critical to quality, manufacturability to scale) from product development stage through a robust MCP- Deep understanding of capacity analysis - annually as well as during production readiness to ensure appropriate capacities are allocated, both holistically and at a program level.- Ability to understand diverse and ever evolving manufacturing processes- Understand process management - able to determine the critical processes to quality and its controls to prevent or mitigate potential issues/risks- Knowledge of tools from Lean/6 Sigma/TOC/SPC to assess factorys performance to supportOBSD strategy :- Technical ability to assess and resolve product and inspection issues- Build ones own technical expertise in a structured and systematic way- Understanding of cost engineering to support factorys drive towards efficiency and right first time quality- Quality Strategy and Management- Understand and be able to assess the effectiveness of a factorys preventive QMS and its sustainability, across diverse manufacturing processesD R A F T :- Drive continuous improvement of a factorys quality management system, shifting focus from detection to prevention.- Plan for quality through preventive product risk mitigation, factory capability assessment and capacity validation prior to production.- Strategic overview of the factorys performance in order to prioritize and identify areas of opportunity to drive elevation- Evaluate the health of the factorys QMS- Support 3rd party escalation, disposition and CAPA reviews for continuous improvement- Understand the guest expectation through voice of the guest- Support ME initiatives focusing on efficiency and right first time quality- Data/Reporting and Analytical thinking- Ability to review data and conduct statistical analysis- Leverage data to identify opportunities for calibration, continuous improvement and problem-solving- Drive cost of poor quality reduction with a focus on greater efficiency and right first time quality- Understand industry and share business intelligence with CFT teams when needed- Engage in proactive sourcing and category management from technical, quality and engineering perspective to drive robust business placement decisions- Extensive use of quantifiable data and KPIs in decision-making; to provide performance feedback to vendors/factories.2. Communication/CFT Collaboration/Training- Share lessons learned in quality planning activities and core processes- Support calibration activities for 3rd parties, vendor and factories- Act as technical liaison between HQ PSQA, Vendor/Factory partners and cross functional teams- Ensure transparency and adherence to escalation process when required- Provide ongoing support to PSQA HQ for continuous improvement, issue resolution and problem solving- Successfully navigate through tough choices and be able to articulate a strong point of view both internally andexternally - to leaders, peers, team members and vendor/factories.- Engage in factory matrix optimization and influence business decisions through CFT collaboration based on business needs and quality performance- Steer decision effectiveness and efficiency; take smart risk based on facts, figures and guest insights throughcritical thinking :- Provide expertise to validate CFTs business decision and increase supply matrix visibility through factory assessment- Engage in new vendor/factory vetting and exploration process that supports sourcing decision-making and long-range business plan5. Operational Excellence and Brand Reputation :- Adapt to change and adhere to Organizational strategy, direction and business goals- Continually focus on and demonstrate commitment to concepts of value creation through COQ/Lean/SixSigma tools/efficiency - Ensure transparency and adherence to escalation process when required- Demonstrate the highest level of ethics; make ethics a mantra for TGT and supply chain- Escalate critical issues concerning ethics, through the proper channels- Provide ongoing support to PSQA HQ and PSQA QMS Team for continuous improvement, issue resolution and problem solving- Support HQ through product investigations and activate on guest data analysis appropriately.- Investigate quality issues, ensure effectiveness of CAPA and validate vendor/factories are driving toward continuous improvement.,

Keyskills :
right first timecertified tips trainerenvironmental impact assessmentcontinuous improvement facilitationquality management systemdata analysisvalue creationrisk assessment