Quality & Compliance Role - Pharma/OTC Products

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 through

QMS 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 factories

Key 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 factory's performance to support

OBSD strategy :

- Technical ability to assess and resolve product and inspection issues

- Build one's own technical expertise in a structured and systematic way

- Understanding of cost engineering to support factory's drive towards efficiency and right first time quality

- Quality Strategy and Management

- Understand and be able to assess the effectiveness of a factory's preventive QMS and its sustainability, across diverse manufacturing processes

D R A F T :

- Drive continuous improvement of a factory's 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 factory's performance in order to prioritize and identify areas of opportunity to drive elevation

- Evaluate the health of the factory's 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 and

externally - 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 through

critical thinking :

- Provide expertise to validate CFT's 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 plan

5. 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.