11 Line Clearance Jobs

1.0 Key or Primary Responsibility: Role & responsibilities 1.1 Line clearance for dispensing raw materials and manufacturing activities 1.2 Document issuance, distribution, retrieval, retention, and management 1.3 In process quality check for drug substance packing process 1.4 Distribution of SOPs, controlled copies of required documents to respective departments. 1.5 Coordination and timely completion of work as per management instruction. 1.6 To make documents controlled, uncontrolled, issuance, obsolete, execution and reference copies whenever required and update the tracking sheets as well. 1.7 To retrieve the executed documents from all departments and filing properly in QA document cell. 1.8 To prepare lists of documents retrieved from all departments and documents available in QA document. 1.9 Stamp management and maintaining properly under lock and key. 1.10 To arrange and label the files in QA document cell. 1.11 Preparation, coordination, and execution of vendor audit. 2.0 Secondary Responsibility: 2.1 Supporting the regulatory department for licensing activities 2.2 Issuance and retrieval of daily and monthly documents. 2.3 Controlling & distribution of the new SOPs to the respective departments, retrieving and destruction of the old-controlled copies of documents/ SOP's 2.4 Responsible for undergoing training in BGL policies and following BGL policies. Preferred candidate profile 3.0 Knowledge and skill set: 3.1 Effective communication skills and Good at Microsoft document editing 3.2 Ability to manage cross functional departments 3.3 Good in handling documentation

Outlines quality assurance procedures and policies Oversees implementation of quality assurance procedures Ensures the efficiency of inspections through hands-on guidance Ensures data integrity and accuracy Prepares reports on the results of quality inspections Evaluates outcomes of quality inspections and proposes corrective measures. Preferred skills : IPQA, Line clearance, BMR/BPR preparation and & Exposure in review Qualification of equipment and HVAC (DQ, IQ, OQ, PQ) Process validation, Protocol preparation and review Documentation, Change Control, deviation, Market Complaint, CAPA, etc.

Online documentation checking in plants to check the compliance of SOP's and to conduct random audits in different manufacturing blocks. To check the adherence to the Quality Management System (QMS) elements, such as change control, incident management, and CAPA (Corrective and Preventive Actions) management on the shop floor. Verification of online filling of BPR/BMR Responsible for conducting line clearance in manufacturing facilities. To verify whether the manufacturing facility always meets basic Good Manufacturing Practice (GMP) requirements, including facility upkeep, environmental conditions, segregation of materials, and status labeling. To verify that manufacturing activities i.e.sampling activities, charging/discharging of material to/from the equipment, weighing balance calibration/verification, cleaning of equipment (PCO and periodic cleaning), powder processing activities and other GMP related activities are being performed as per established procedures. Verification during process validation and Equipment Qualification activities.

A. Job Objective Monitor and review In Process quality control checks to meet the required quality compliance as per specifications. Strategic and planning Functional Core:- Review and provide decision based on the IQC sheet Online feedback to production for correction Daily plant round for ensuring compliance of SOPs, GDP, GMP guidelines etc. on the shop floor Refer ZMIC for special instruction during color change/ product change and guide the IQC operator for the same. Review the implementation of the same. Monitoring CAPA during shifts. Investigation of internal stranger/failure to identify the Root cause analysis and take corrective/preventive action for the same. Track instance of repeat failure from operators and take measures/set processes to avoid re-occurrence of the same and to ensure FTR. Line clearance of camera inspections, HCM, ATS, printing machines and Final Inspection System Ensuring document verification generated during shift on daily basis against defined standards Internal process Preparation of various reports Maintenance and verification of gauges to ensure proper calibration of these equipments on a regular basis in each shift Ensure verification of shade against master and Macbeth report Verification of daily profiles and online graphs Periodically conduct process, product and systems Audit. To provide data for annual product quality review & Participate in APQR and finalise the recommender's People development Ensure proper manning and shift handling, shift activities. Effective training to the operators with evaluation for compliance. Effective manning to utilization of available sources.

Exciting opportunity for IPQA Executive at our EU approved OSD Manufacturing faculity (UNIT 1) @ Moraiya, Ahmedabad!! Company : Unison Pharmaceuticals Pvt Ltd Website : www.unisonpharmaceuticals.com Location : UNIT 1 , Moraiya, Ahmedabad Experience : 4 - 9 Years Dept. & Sub Dept. : QA - IPQA - OSD MFG Designation : Executive Job description (Not limited to): Collect in-process and Finished sample as per Specifications and Protocol. Check documents like equipment log books, temperature & humidity records. Line clearance of machine & manufacturing area . Checking of batch manufacturing record. Perks & Benefits Dynamic work environment Career development opportunities Work-life balance Free transportation Canteen facility Free insurance coverage for self, spouse, and kids Range of learning opportunities to help employees grow and thrive If you are passionate about continuing to work in the pharmaceutical industry and possess the required skills, we encourage you to apply for this position. Please submit your resume to career@unisonpharmaceuticals.com to be considered for this role. Join our team at Unison Pharmaceuticals and take the first step towards a rewarding career.

Role & responsibilities We are looking for candidate on below criteria at our Nalagarh Plant Himachal Pradesh location. Candidate must have completed Pharma, M.Sc. or B.Sc. in Chemistry. Experience of regulatory industry would be preferred. Candidate should have 1-3 years of working experience Preferred candidate profile Responsible for Line clearance in Warehouse and Production area during dispensing, MFG, Filling and Packing & review of log books and status label of each equipments before start of activity. Responsible to carry out in-process checks as per respective Batch Production Record in Manufacturing, packing and warehouse. To ensure that the manufacturing and packing operations are carried out as per the instructions given in the Batch Production Record. Responsible for collection of in-process samples, FP sample, control samples, validation & stability samples. Responsible to make SAP entries, Release of inspection lot of SFG & FG, Physical sampling confirmation, Approval of Batch Production Records for printing and additional page issuance. Responsible for online review of Batch Production record and make entry of data required for trending in maintained excel sheet for preparation of APQR. Responsible for Line clearance in Warehouse and Production area during dispensing, MFG, Filling and Packing & review of log books and status label of each equipment’s before start of activity. Responsible to carry out in-process checks as per respective Batch Production Record in Manufacturing, packing and warehouse. To ensure that the manufacturing and packing operations are carried out as per the instructions given in the Batch Production Record. Responsible for collection of in-process samples, FP sample, control samples, validation & stability samples. Responsible to make SAP entries, Release of inspection lot of SFG & FG, Physical sampling confirmation, Approval of Batch Production Records for printing and additional page issuance. Responsible for online review of Batch Production record and make entry of data required for trending in maintained excel sheet for preparation of APQR. Perks and benefits

Role & responsibilities For IPQA packing line as well as Manufacturing IPQA - Line clearances Interested candidate can share CV on mrunali.uttekar@bdrpharma.com

Job Objective - Maintain line continuity, productivity, quality of product, reduce wastages and adherence to cGMP, GDP and safety in-shift for the allocated line(s). Roles and Responsibilities - Check the allocated post production (ATS/Printing /camera)- line(s) in each shift as per the CTQ (critical to Quality) /CTP (Critical to Productivity) checklist Follow plan as per color change note by ensuring minimal change over time at each sub section Follow instructions from shift lead for timely change over by ensuring availability of roller(s)/ink etc Execute IPQC after every roller cleaning and checking of rejections of camera(s) after every hour for achieving zero defect Execute camera operations as per SOP to achieve productivity and quality Coordinate with contract associates to follow SOP at ATS /Camera/packing /Sealing and tumbling Execute preventive maintenance plan for line(s) to achieve zero downtime of the line(s) Execute troubleshooting activity for entire line(s) to achieve productivity. In certain cases, seek help from maintenance team for uptime of machine Reporting and controlling post production loss of printing and camera to achieve Targeted AFOE@Despatch Follow cGMP and GDP for allocated line (s) for ensuring regulatory compliances during the shift. Follow instructions from shift lead/team lead to implement CAPA for any customer complaint(s) Assist other line operator during colour change /Break down for timely start-up of line Making downtime and rejection entries on daily machine performance report Communicate attribute defects to Production /line lead on continuous basis Machine cleaning Shift handover and takeover Safety

Role & responsibilities 1. Line Clearance in all stages. 2. Sampling all stages. 3. Validation. 4. Control Sample Management 5. APQR 6. QMS Review. Interested Applicant can send CV on janhavi.shedekar@mjbiopharm.com or contact on 9867700982

-We are looking out candidates for different sections and positions in Quality Assurance department. Such as IPQA, QMS, Lab QA, AMV QA. Interested candidates can share their resumes on a.salunkhe@v-ensure.com & n32admin@v-ensure.com Role & responsibilities 1) IPQA - In process Checks. - Line clearance - Review of BMR, BPR 2) QMS - Handling and review of Change control, deviations, CAPA of different departments. - Document issuance, archival, retrieval. - Facing the Audits. 3) Lab QA & AMV QA - Managing Analytical QA activities. - Review of documents related to QC i.e. Raw material, finished products, stability. - Review of documents of Method validation, Assay. Preferred candidate profile - Candidates must have experience in Pharma formulation plant. - Must have good communication skills. - Candidates from Regulatory plant will be given preference. - Immediate joiners will be preferred. Perks and benefits Best in the industry

• Responsible for line clearance in production. • Responsible for monitoring of on line compliance in plant. • Responsible for ensuring cleaning of plant. • Support during investigation. • Handling SAP as per responsibilities