Formula & Regulatory Specialist

Key roles and responsibilities of this position

This position is a key role in the QSE team in the Plant and is the final custodian of the correctness of the Bill of Materials (BOM) & master data setup which will define the product made by the Plant is in accordance to the approved formula issued by Corporate through the Country of Sales Document (COSD).

• Execute activities related to design, creation, extension, data consolidation and validation of master data.
• Responsible for data lifecycle management and providing relevant analytics to the Global MDM team
• Ensure In-process inspection for intermediates and finished products in SAP is correct
• Provide formulation information to Operations to create recipe andinput special intructions in the Standard Mixing Instruction (SMI).
• Ensure accuracy of manufacturing recipe in the Human Machine Interface program which control the batching of products.

Validate that the recipe and SMI will meet the design and capability of the equipment setup for manufacturing.

• Generate the product label Master image and is the final approver for the accuracy of the product label to customers.
• Generate & review SDS to meet custom requirements for shipment of products.

In regulatory area –

• Provide regulatory expertise and serves as an internal consultant on regulatory issues and decision making relative to GHS, Customs and Heath authorities regulations and company specific requirements. Liason with SRA BU, R&D and Corporate.
• Leverage business relationships and influence leadership and operations to support, communicate and drive the execution of current and future program for regulatory compliance as well as provide technical expertise
• Work in collaboration with R&D in order to reduce time to market, improve productivity and flexibility, reduce complexity, logistics cost reduction, re-apply ideas & leverage intellectual property across the System, minimize write-offs, optimize product and packaging and Increase equipment utilization
• This position will work very closely with the Product Portfolio & Global Master Data Teams, OU -SRA, TCCC- SRA to ensure effective execution of duties.

Key Duties/Responsibilities:

MDM 35%

Create, amend & cross Validate BOM

• Translate formula and technical review information into master data elements to be updated in SAP and related systems. Create, validate through audits, and maintain master data (material master, BOMS, Master Recipes, AFL) in the SAP R/3 production module for materials, raw materials, in process, finished goods and sales kits.
• Maintenance of Business Continuity Master Data for Contingency Supply Points to meet the Enterprise Risk Management (ERM) requirements.Material Master Creation, Validation, Maintenance

• Creation & validation of correct Master data in various tabs of the Material Master, Recipe Master which include net and gross weight, storage condition, shelf life, alternate units of measurement and packing configuration.
• Upkeep and validate all formula assigned to the Plant through Country of Sales document (COSD) which is active and current.
• Data quality reporting (metrics and compliance) – Includes the design, execution and publishing of data quality and compliance scorecards.
• Create working note and get it approved.                                                                                                                                              Regulatory                                                                                                                                      45%

FSSAI Licensing and compliance to food safety standards

• Lead FSSAI and other food regulations required for CPS Pune to company for its domestic and export business. License renewal, Modification, annual returns, fulfilling condition, inspections, addressing notices, etc.
• Ensure testing compliances, training and other records are maintained and up to date
• Read and interpret regulation and changes to it. Collaborate / align with OU SRA , TCCC SRA for statutory submission.
• Follow up with specific authorities in case of delays in import materials.
• Have good record keeping practice.

Intellectual property

• Develop solutions for disclosures requested by Customs and Health officials
• Approve new statements provided to Customs and Health authorities concerning the composition of our ingredients and beverage bases with Corporate approva Maharashtra,India.

• Assign tariff codes for import of ingredients and export of finished products
• Give support in issues regarding tariff codes
• Provide support in contingency plans. Act as SME and liason with BU

New Regulations

• Give support to CPS, BU and bottlers in new requirements implementation involving CPS processes
• Coordinate the analysis and interpretation of the regulations and scope
• Provide guidelines based on Corporate validation

Support Food Safety System Management

• Lead GHS implementation for finished products, assuring accomplishment with country of sales regulations. Work in collaboration with R&D for reformulations to avoid not expected hazards
• Support to Allergen program  and Validate Concentrate labels
• Identify safety, food safety, environmental and quality risks and/or opportunities, and apply problem solving tools to ensure conformance and continuous improvement of processes. Ensure the organizational knowledge maintenance.

Value Design activities

•  Provide flexibility and productivity, reducing time to market and costs through a draft prototype formula analysis
• Support new supply models according to business needs: acquisitions, supply point shifts, etc
• Improve supply chain through collaborative work with R&D on formula design, reducing operational complexity, ensuring supply continuity and optimizing costs before first manufacture

Finished product label approval                                                                                                                            10%

• KO art work, Winshuttle and label template creation
• Setting up GLS Master data and ensure it is ok for production in CPS Pune
• Check with  importing country SRA for any specific regulatory requirement on labelling.
• Provide information to Operation for creating the label template, verify the correctness of the template created and give the final approval for use.
• Communicate changes to the label to customer service.
• Coordinate relabeling activities brought upon changes in the product label.
• Maintain the approved label database.
• Create SDS and other documentation requirement for shipping and custom clearance.  5%

•  Check with importing country SRA for any specific regulatory requirement.
• Provide product information declaration, Certificate of Analysis or Conformance on the products to be shipped.
• Obtain the necessary regulatory document required by importing country such as health certificate or free sales certificate.
• Create the Safety Data Sheet (SDS) document for all the parts in the kits.
• Upkeep the SDS for active formulas assigned to supply by the Plant.
• Lead and/or participate in Formula and Regulatory projects in CPS Asia.

• Review and feedback KORE changes regarding Master Data in CPS Asia.
• Lead root cause analysis sessions to resolve non-conformance identified.
• Jointly work with R&D, Operational Excellence and Product Portfolio Teams in value creation initiatives (e.g. formula rationalization, formula change and ingredient substitution, etc.).
• Data Lifecycle Management – routine review of all master data object to identify and obsolete redundant data.
• Data analytics, mining and Reporting – as requested to support the business functions and processes.
• Support Development of Data Standards – working with the MDM governance team to design, implement and retrofit standards.

Organization Impact/Influence:

This position works closely with senior management and plant’s associates in providing safety & environment recommendations to comply with requirements. Interactions include, but not limited to:

Internal interactions:All functions

External interactions:

• CPS SRA / MDM Team
• Product Portfolio team
• Local Government Authorities for Food safety and FDA (as required).
• Third parties service providers
• Professional bodies / consultants/Third party labs to improve food safety regulations

Related Job Requirements/Qualifications:

• Master is Food technology, Life sciences, Chemistry, or equivalent.
• Working experience – Minimum 6-8 years in manufacturing company in similar positions. Should have knowledge of Food safety and production line knowledge in CPS OR should know manufacturing workflows, knowledge of processes in food industry. Hands on SAP knowledge and MDM work experience.
• Company (“System”) knowledge, such as organizational structures, policies, Product Approval Request , Product Stewardship, Regulatory, customers(BU’s) and other stakeholders (suppliers and bottlers).
• The job requires accuracy, discipline, consistency, and pro-activity in all duties to deliver on time.

• Technical Knowledge – Good knowledge of central and local Govt. regulatory requirement related to food Safety, import and export related to food regulation. Knowledge of various labelling requirements of food items. GHS, GLS, Allergen, GMO, PICASSO,KORE, GMP, etc.

Knowledge of food ingredients, packaging, Data analysis and reporting.

Various standards like BIS, JECFA, Pharmacopeia, HALAL , KOSHER, etc requirements.

• Analytical Ability – Support in decision making by providing accurate data. about Trends, Internal auditing.
• Interpersonal relationships – Networking and Wworking with others. Shows respect, trust and good team member.

Communication –

• Planning and Organization – Set priorities and organized for meeting timelines
• Influencing – Accepts other views and implement required solution yet in agreement of others. Takes the view of others.
• Ability to apply technical knowledge and establish credibility with highly technical audiences in order to build relationships
• Ability to recognize and protect proprietary information as it relates to formulas and ingredients
• Attention to detail and focused work with full concentration to avoid any error / mistake in MDM/BOM/ Recipe
• Decision making ability and effective communication,
• Collaborate and contribute to the success of the team, tolerance to stress, manage workload, take risks, and develop positive work relationships with external areas.