4 Change Controls Jobs

Handling, storage and retrieval of all the documents pertaining to facility on operation of the functional departments. Deploying Good Documentation Practices throughout all the functions. Allotment of reference numbers, Formatting, distribution, control, revision, retrieval and storage of all master documents. Maintaining of master list of documents. Maintaining online documentation. Issuance of Formats, LNBs & Log books to all departments. Preparation of QA&RA SOPs. Monitoring of Instruments and Equipment calibrations. To involve internal quality and regulatory compliance audits across all the functions. Handling of Training Records across all the functional departments. Monitoring for compliance across all functional departments. Providing adequate support to R&D teams to execute the required documents for regulatory submissions. Review of all quality documents which includes SOPs, Formats, Equipment/Instrument qualifications/ calibrations , drug excipient compatibility studies, API characterization, API solubility studies, Stability studies, Stress studies, Other studies, Method development reports, Specifications, STPs, MFR, method validations, Method transfers, PDR etc. Reviewing of LNBs, Raw data & Log books for data integrity issues.

Job Description : Business: Pharma Solutions Department: Engineering Location: Digwal Travel: NA Job Overview To maintain the GMP & EHS Documentation related to E&M Key Stakeholders: Internal Production, QA, EHS Key Stakeholders: External Regulatory, Customer Reporting Structure AGM - E&M Positions that report into this role Executive/ Sr. Executive / Dy. Manager Experience 12 years and above Job Description: Responsible for carrying preventive maintenance as per schedule. Should be capable of handling Quality, EHS Audits. Should have in-depth knowledge in cGMP/USFDA Documentation Should have in-depth knowledge in Current safety systems/safe working practices. Person should be capable to Train & lead the Team Should be familiar with online GMP documentation. Should be familiar with Root cause Analysis tools. Should have in-depth knowledge on Equipment Qualification, Preventive maintenance documentation, ISO documentation, SAP knowledge. Responsible for preparation of SOP's, HVAC protocols and validation reports. Should be familiar with Change controls, Deviations, Risk assessments Should be familiar with process equipment like Reactor, centrifuge, ANFD, RCVD, Blender, sifter, multi mill, FBD etc Should be familiar with Utility equipment like Boiler, Air compressor, nitrogen plant, chillers Responsible for preparation of all types ofschedules and follow-up with user departments Responsible for Audit compliance, CAPA closing. Co-ordination with QA, production, EHS and Engineering team.

Responsible for Overall site QA compliance activities and drive the organization towards quality improvements Handling of Deviation, Change controls, OOS, OOT and CAPA including investigations and impact assessments

Biocon Biologics Limited, a subsidiary of Biocon Limited, is a fully integrated global biosimilars organization. It is leveraging cutting-edge science, innovative tech platforms and advanced research & development capabilities to lower treatment costs while improving healthcare outcomes. It has a strong research pipeline of biosimilar molecules across diabetes, oncology, immunology, and other non-communicable diseases. Six molecules from Biocon Biologics portfolio have been taken from lab to market in developed markets like United States, EU, Australia, Canada and Japan. With a team of ~ 4,800 people, Biocon Biologics is committed to transforming healthcare and transforming lives by enabling affordable access to millions of patients worldwide. Education: BE/BTech , BPharma , MSc, MPharna Experience: 4-7 years Key Skills: Shiping Validation, Change Control, CAPA, Deviations Primary Responsibilities To handle end to end shipping validation related to various products comes under cold chain scope for new products/routes/modes/new pack profile etc. To generate technical documents and risk assessments to leverage validated shipping routes to others. To write the shipping validation protocol, execution, and report preparation in collaboration with CFTs. To support introduction in active solutions as part of cost-effective and ESG initiatives. To ensure all QMS records such as CCF, CAPA, Events, CAPA effectiveness check etc. are timely initiated, reviewed and closed in coordination with internal external CFTs timely without any delays and extensions. To support operations team with respect DR (dispatch record) review and timely make it effective for hassle free execution of shipments. Timely investigate shipping related incidents and facilitate the batch release. To create the data base for shipping validation for various Lanes/routes/mode of shipment/Load pattern/Volume/Passive/active mode etc. Coordinate & Manage relationships with Internal & external stakeholders for flawless execution of QMS activities. To ensure mandatory and periodic training are completed Identify potential risks and develop strategies to mitigate them. To closely work with operations team in upkeeping facility and to ensure audit preparedness. To face regulatory, customer/consultants/Internal, statutory and safety audits as part of WH and logistics compliance. To provide timely response to all QA internal/external audit and implement CAPA holistically. To perform Internal audit at all WH locations and close the audit loop To ensure all digital projects are effectively implemented with CFT collaboration, automation, migration from manual process to electronic etc., Review of URS, Risk Assessment, Impact Assessment, Protocols, and Reports for the equipment and facility qualification. Establishing and review of EHS objectives, targets and management programs in the department. To support quality team regarding QMS review, PQRs, Trend report, facility review reports etc To Adherence to CGMP and EHS norms as per the outlaid procedures and regulatory guidelines. Adhere to the companys policies and ensure to align the warehouse activities to meet the companys business goals.