Junior Manager Quality Control-Biologics

Job Description

• Responsible for preparation of documents such as SOPs, IOPs, EOPs etc.
• Receiving of Base documents of Raw materials, Process consumables & Packaging materials from MSAT team and verification of respective documents against monographs / Vendor C of A.
• Preparation of specification, method of analysis and observation data sheet.
• Static data creation in LIMS and validation of created data in LIMS Validation mode.
• Coordination with LIMS core teams for migration of validated data to LIMS production.
• Verification of Chemicals / Standards required for new materials and creating purchase Request for procurement.
• Providing draft Specification, method of analysis and observation data sheet for introduction / revision of specifications to initiate the change control in Trackwise.
• Preparation of final specification and submission to QA for approval.
• Submission of approved specifications to QA archival and Providing training (GTR) on the same to respective QC personnel.
• Verification of GRN with approved specification and allotment of AR numbers in LIMS.
• Document preparation in EDMS.
• Creation of Purchase request for outsourcing tests
• Documentation of consumables and raw material reports.
• Allotment of work to analysts in LIMS.
• Final COA preparation for raw materials and packing materials.
• Feasibility verification and coordination with approved third-party laboratory for quotations and analytical reports.
• Creation of inspection plans in SAP in SAP as per specifications of RM, PM and process consumables.
• Monthly report preparation and providing data to Project team and MERM slide.

• Responsible for uploading and assigning SOP / EOP / IOP in LMS.
• Responsible to involve and participate during the preparation and general laboratory readiness for the internal / external / client audits.
• Responsible to complete all planned quality & compliance training as and when required by the department / section or asked by the HOD / Section Head.
• To prepare the complete list of materials (CLM) required for various project.
• Responsible to initiate and inform immediately to department HOD/designee, if there are any laboratory incidents, deviations, change controls and out of specification results were observed.
• Responsible to conduct any job assigned by the superior.
• Responsible for the training coordinator activity which includes providing of training questionnaire, submitting the GTR to archival QA, preparation of JD, training matrix, training binder, review of training files and assigning training in LMS.
• Perform sample management duties which may include movement and storage of samples, reconciliation of sample receipt and aliquoting of samples.
• Responsible for the preparation of stability study related documents like, stability study protocols, observation data sheet, analysis report, stability summary and trend sheets. Responsible for the execution of stability samples charging for stability study.
• Follow environment, health, and safety (EHS) requirements at all times in the workplace ensuring individual and lab/plant safety.
• Attend training on environment, health, and safety (EHS) measures imparted company.

Educational Qualification: Masters in Chemistry (Any Masters in science)Experience: 6 8 yearsTechnical Skills

• Planning and execution of Raw materials, Process consumables and Packaging materials and verification of respective documents against monographs / vendor COA.
• Assistance in setup up of RMPM lab as per the direction of Supervisor/Section Head.
• Preparation of documentation such as SOPs, IOPs, EOPs etc.
• Preparation of batch release documents like specifications, STPs with observation data sheet, verification protocols, method transfer protocols etc.
• Responsible to perform the method transfer analysis and verification activity with documentation for the samples of in-process/finished product

Behavioral Skills:

• Strong commitment towards work, and a high level of dedication, enthusiasm, motivation, and persuasive ability in a team.
• Good speaking-listening-writing skills, attention to details, proactive self-starter.
• Ability to work successfully in a dynamic, ambiguous environment.
• Ability to meet tight deadlines and prioritize workloads.
• Ability to develop new ideas and creative solutions.
• Should able to work in team and flexible for working in shifts.
• Should be a focused employee.

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Keyskills :
quality controlcalibrationisoinspectioncommitment towards workequal employment opportunitycontinuous improvement facilitationanimal health