About the Company
Biocon Biologics is a subsidiary of Biocon Ltd, an innovation led global biopharmaceuticals company.
Biocon Biologics is engaged in developing high quality, affordable biosimilars that can expand access to a cutting-edge class of therapies to patients globally.
It is uniquely positioned as a fully integrated 'pure play' biosimilars organization in the world and aspires to transform patient lives through innovative and inclusive healthcare solutions.
The Company has a large portfolio of biosimilars under global clinical development with three of these commercialized in at least one of the developed markets of EU, U.S. and Japan.
Biocon Biologics has a product pipeline of 28 molecules, including 11 with Mylan, several with Sandoz and is developing many independently.
Biocon Biologics believes that strong partnerships offer enormous opportunities to co-create the future of healthcare, building a patient ecosystem beyond the product, which can transform millions of lives.
Website:https://www.bioconbiologics.com
Role:QMS LEAD - SCM WAREHOUSE & LOGISTICS
Location:Johor Bahru, Malaysia
About the Role: QMS Lead WarehouseAs a Manager, this Role will be responsible for ensuring overall GMP compliance at Malaysia Warehouse.
This role will closely coordinate & collaborate with the WH Operation leads, QA, QC, Engineering, Regulatory, Program management, SCM team and other Cross Functional Leaders, with a commitment to Quality, Regulations & Safety guidelines, be a Champion of Change and drive the Warehouse compliance towards progress in sync with the organisation's progress map.
JOB Description:Lead Current & upcoming QMS document in Warehouse and ensure timely closure of the same within initial target date.
To lead the change implementation related to facility, procedure and new projects with Quality and other cross functional team.
To ensure that changes are adequately evaluated for its impact on quality, safety and regulatory filing and ensure its effective implementation and closure of respective QMS records.
To handle quality risk assessment for implementing changes using various tools and quality and regulatory guidelines.
To investigate deviations, OOS, Environmental Excursions (OOAL and OOAC) in a timely manner with support from CFTs and closure of the same within the due date.
To lead the GMP audits in Warehouse from regulatory agencies (USFDA, EMA, NPRA, PMDA, TGA etc.)
and customer, certification body and Internal audits.
To prepare response to the audit observations in line with quality expectations and implement CAPA holistically.
To lead and ensure temperature mapping for Warehouse storage areas and equipments (cold room, deep freezer) are completed within the scheduled date.
To review the existing procedure across the locations for standardisation and introducing the new Harmonization SOP for global functions.
To track all QMS records for its progress and measure QMS performance in line with approved SOPs/regulations and appropriate quality tools.
To be aware of digital tools like Track Wise, DMS, LMS, eVLMS etc.
Coordinate & Manage relationships with Internal & external stakeholders for flawless execution of QMS activities.
Identify potential risks and develop strategies to mitigate them.
To present compliance functions progress to Senior leadership on monthly basis.
To ensure all digital projects are effectively implemented with CFT collaboration.
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.
Timely escalation of the issues to senior management with respect to quality and safety.
To Adherence to CGMP and EHS norms as per the outlaid procedures and regulatory guidelines.
To ensure mandatory and periodic training are completed for self and team.
Adhere to the company's policies and ensure to align the warehouse activities to meet the company's business goals.
ADDITIONAL RESPONSIBILITIES:To execute the additional activity instructed by Team Lead/Department head as per needs.
To participate/execute Internal audits across the Warehouse.
To support for all regulatory audit preparation and execution across the location as needed.
QualificationsBachelors or Masters, preferably with MBA in Supply Chain or relevant stream.
Equal Opportunity StatementBiocon Biologics is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, disability, or veteran status.
Biocon Biologics also complies with all applicable national, state and local laws governing non-discrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act.#J-18808-Ljbffr