Job Description

Primary Objective

Batch review and release procedure at site including maintaining quality department documentation and associated filing, logging and processing of documents and quality records. Work with all functions within Abbott Nutrition Jhagadia to provide document control and related services, generate documents and records and communicate status.

Major Responsibilities:

• Perform Batch review and release activities including processing of review, approval, and filing of completed Documents releted in line with global requirements releted to batch release.
• Review the various quality system files and associated documentation including CAPAs, validations, SOP, audits, training, etc. Maintain on-line database and support in managing and improving the ongoing batch log auditing and release system.
• Coordinate the collection of all associated quality records from manufacturing, installations/servicing, customer support, etc.For e.g: CoA, Consumables Approval activity, maintaining system database and establish a tracking and reporting system for documents as directed.
• Provide administrative assistance intra-departmentally for Regulatory and Quality Systems activities. Prepare documentation to be included in regulatory submissions and other quality activities and file accordingly
• Provide documentation support to various inter-departmental teams and activities. Work with project team members and independently in support of documentation services needed to achieve planned deliverables and timeframes.
• QA Documentation Executives coordinates and prepare document packages for submission to regulatory agencies. They compile all materials required for regulatory submissions, license renewal, and registrations. They must stay current with regulatory procedures and changes.
• Ensure SAP related compliances i.e. Code Creation, SAP Inspection plans etc.
• Ensure to prepare Product sampling plan and circulate with team within timeframe if applicable.
• Support to QMS for Mock recall and traceability activity.
• Support to QMS for Internal Audit and External Audits.
• Responsible to share BRFT and NRFT data with management as per timelines.

Comments:


Key Behavioral Competencies Required: Adaptability, Innovation, Initiative, Teamwork, Integrity

• Interpersonal skills in order to have healthy relationship with colleagues working in different functions at site.
• Communication skills in order to understand and provide necessary feedback or solutions within the QA team and internal customers.


Environment , Health and Safety:

• Ensure self and team members consistently follow all EHS rules and procedures.
• Ensure self and team members immediately report any EHS incident and/or near misses (unsafe acts and conditions) promptly to supervision.
• Attend all required safety training and medical surveillance program requirements.
• Ensure self and team members wear all required PPE.
• Consistently take a leadership role in identifying team members who are and are not following procedures
• Complete required STOP observations
• Incur zero injuries of self and team members as a result of unsafe action/behaviour or failure to follow established procedures or guidelines.
• Identify and report to supervision opportunities to reduce energy and water use, waste generation within your work area.

Education:

• Degree in dairy or food sciences or related field like Masters Degree in science with 2 to 4 years of experience in quality control or quality assurance department
Background:

• Thorough knowledge of general/pathogenic Analytical analysis procedures
• Understanding of Quality systems ISO 9001/ISO 22000/ FSSAI /BIS / Risk Assessment and exposure for HAZOP/HACCP analysis is desirable.
• Experience in processing, reviewing and filing hard and soft copy documents, preferably within the quality department in a Nutiritonal or similarly regulated industry.
• Experience and understanding of document control practices and related activities
• Excellent organization and filing skills, both hardcopies and electronic file management, consistent attention to detail
• Effective interpersonal and communication skills.
• Ability to work independently and manage assigned responsibilities and projects.

Accountability & Scope:



The job holder is responsible to develop good documentation practices in the plant and should be responsible for documentation of all the functions related to batch record within Abbott Nutrition Jhagadia.