Objectives of the Position

1. Develop, monitor, and implement quality control & assurance procedures and policies according to corporate standards .To ensure that raw materials meet the specification requirements , products satisfy customer expectations and achieve superior reliability by utilizing the available manpower and equipment, whilst maintaining good standards of safety and resource conservation to achieve the set targets.
2. Compliance of all EHS and RC requirements.

Main Areas of Responsibilities and Key Activities

Main Responsibility

QA Related:

• To ensure the quality of incoming raw material / packing material, in process material and finished products including application test.
• To ensure the approval of raw material / finished products in system (SAP / QSIS) and COA to the customer.
• To design / modify specifications of Raw material , Finished products , Packing material
• To investigate customer complaints (Quality related) and feedback to marketing.
• Overall implementation & maintaining of Management systems like ISO 9001 / 14001 / RCMS/RSPO/Effci GMP.
• To ensure the compliance of internal / external audit findings related to all above management systems.
• To upgrade testing facilities and test methods and optimize testing parameters for raw material, in process materials, finished goods.
• Maintain & up keep of testing equipment.
• Make the budget.

EHS & RCMS Relate:

Responsible for Product Stewardship functions at Site.

• To ensure the adherence of EHS rules and implementation of RCMS in the QA lab.
• To ensure the safe and healthy work environment.
• To ensure that good house keeping is maintained and PPE rules are followed.
• To ensure the safe handling of chemicals and availability of MSDS.
• To ensure that permit system is followed properly.
• To ensure that waste management is done properly and waste is disposed of as per written procedure and guidelines.
• To ensure that departmental safety committee meeting is conducted and minutes is circulated to the concerned.
• To ensure that legal and other compliance is fulfilled in respect to department.

Critical Problems/Challenges

• Assurance of quality of raw material and finished products.
• Continuous improvement of knowledge about the ISO 9001 / 14001/ RCMS.

Effci GMP Related Role’s & responsibility:

• Review and approve GMP related documents which impact on Product quality of CI (QA EM plant, Warehouse, Engineering etc).
• Performing risk assessments required by GMP for CI
• Approving suppliers of quality critical materials and services
• Approving or rejecting raw materials, packaging components, intermediates and finished CIs
• Reviewing records to ensure no critical errors have occurred
• Investigating critical errors in records
• Participating in authorizing changes to processes, specifications, procedures, test methods
• Investigating failures and complaints
• Accepting or rejecting CI if it is made, processed, packaged or held by another company
• Training personnel in good documentation & EFfCI GMP standard.

RCMS Responsibilities: The Plant Managers and Functional Heads are responsible to the Site Director for directing the EHS Policy and RC requirements within their designated area.

The particular Responsibilities and Accountabilities are to….

• Ensure that each employee is trained in the RC requirements of his job. Ensure that RC training is planned, arranged, executed, reviewed and recorded.
• Ensure that employees have a safe working environment including the correct protective clothing, equipment and materials.
• Audit and monitor safety conditions and performance in their departments.
• Ensure that supervisors are accountable for carrying out their responsibilities as per the RCMS Manual.
• Involve all personnel in seeking out unsafe acts and conditions, reporting them and eliminating them.
• Ensure that contractors working on site are accountable to the spirit of the EHS Policy and RCMS.
• Ensure that Plant changes or modifications are carried out in accordance with the Management of Change procedure.
• Investigate all accidents, incidents or near misses in accordance with Accident Investigation procedure.
• Ensure that MSDS are available for all Raw materials and finished products processed within their designated area.
• Define RC objectives and Targets and monitor the performance status.
• Performs the role as defined in On site emergency plan to mitigate the emergencies.

RCMS Team Responsibilities:

The RCMS team defined in the RCMS Organogram are responsible to the Site Director for directing the respective RC Code requirements for Dahej site.

The particular Responsibilities and Accountabilities are to….

• Preparation of documents and procedures of respective codes
• Implementation and monitoring of RC systems defined in the RCMS Manual
• Review and revision of documents, procedures in coordination with Functional Head – EHS

Job Requirements

Edu c a t i o n: B.Sc/M.sc

W o r k ing E x peri e n c e: 10 years & above

T e c hn i c al & Pro f e ss i o n al Knowledge: Knowledge of Analytical Instruments, Sampling RM, FG, Inprocess material, Good Laboratory Practices, Integrated Management System, Root Cause Analysis, Customer Compliant handling