Job Purpose :

- To ensure that inspection and all related activities are carried out as per the defined quality system and necessary decisions are taken as per defined process.

- Ensure that the process requirements are periodically reviewed and improved along with any applicable process corrections

1. Ensure compliance to ISO 9001:2015 standards at the workplace

2. Ensure products are scaled-up successfully as per defined procedural requirements.

Primary Responsibilities :

Daily activities :

- Testing and inspection of raw materials, packing materials, intermediates and finished goods across all 3 shifts

- Physical verification of material status

- Handling and maintenance of test equipments like GC, HPLC, UV Spectro-photometer, FTNIR etc

- Performing physical, chemical & microbial tests

- Handling rejection managements with raw material & packing material vendors in co-ordination with central Purchase functions

- Getting the details about status of different batches in various Reactors, TSDs, mixers etc from the preceding shift Officer-Level I.

- Making a list of approved, pending materials & batches and obtaining any special instructions or communication

- Ensuring implementation of 5S & Hygiene related activities on the shop-floor and QA lab.

- Shop-floor audits

- Making daily rounds to the shopfloor and processing floor to ensure that the activities are carried down as per the laid down procedures/systems.

- Ensuring the regular updation of various ledgers and log books regarding the parameters checked for incoming materials and production batches and other tests done.

- Undertaking periodic calibration of various instruments like color-computer, Particle-size analyser, HPLC, pH Meter etc for usage.

- Analysing batch cards of finished products intermediates for observed deviations in process controls, availability of data for future analysis etc.

- Coordinating with materials and production in case of deviations w.r.t completion of batches, recording details of the same and ensuring that these do not recur in subsequent batches.

- Ensure compliance to Packing commodity act for the packed materials

- Co-ordinating with various internal & external stakeholders for effective completion of works

- Schedule and take PEL & pilot scale batches as per plan at a defined frequency

- Co-ordinate with all stake-holders for material arrangements and consumption/disposals

Periodic activities :

- Getting the weekly/ monthly plan from the Planning department and checking for the availability of specifications, test methods, Master samples, and Standard shade panels.

- Analysing customer complaints thoroughly as per the system guidelines and handling customer queries.

- Doing root-cause analysis for product & packing related issues if any

- Ensuring that feedback for customer complaints goes within 48 hours for product complaints and within 24 hrs for packing complaints.

- Conducting of various products cum process audits, packing audits, batching audits etc.

- Conducting Other Tests, stability studies and exposure studies as per the required frequency/requirement and keeping all stakeholders informed of the progress.

- Necessary activities to be conducted for introduction of any new raw material and/or packing materials as per procedural requirements.

- Ensuring that master samples are generated before one month of the expiry period.

- Ensuring that standard shade panels are procured from technical function one month before the expiry period.

- For new designs, ensuring that the PEL, Pilot and first three batches of shop-floor are processed effectively and subjected to other tests and sending the samples to Technical Function. Communicating the results to respective persons.

- Preparing and providing all the necessary data required for monthly report preparation.

- Providing the necessary support for analysis of deviation material & batches.

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