Manager- Quality Assurance

Job Details

Job Title: Manager- Quality Assurance

Department: Quality Assurance/ Quality Control

Functional Area: Quality Assurance

Type of Job: Permanent

Location:Dahej

Job Purpose

• To develop quality orientation and culture; To manage the end-to-end Quality processes, Audits and Customer compliances of Dahej

Role and Responsibilities

Operational:

• Carry out periodic internal audits to ensure compliance to the policies and procedures
• Reporting of the quality system performance metrics, including trends, that help decision-making and taking proactive targeted actions
• Ensure that appropriate manufacturing in-process controls are implemented, and IPC results are satisfactory
• Ensure effective functioning of the QC lab and ensure release of RM, WIP, PM & FG are done against the decided specifications using validated test methods
• Review and approve/reject any document that gives work instructions and set requirements such as procedures, protocols, test methods, and specificationsincluding changes to these documents
• Review and approve/reject reprocessing and rework procedures
• Review and approve/reject production batch records and make the final decision to release a product lot
• Report on product, process and system risksand keep management informed
• Report on outcome of regulatory, customer inspections/audits and ensure responses are complete and managed to verifiable closureand keep management informed
• Development of desired Quality Systems based on the guidelines and standards of ISO 9001 and GMP at the Unit 2 site.
• Implementation of Company Quality policy & Regulatory Compliance across the functions at site.
• Develop a set of QM standards of LOIL which will encompass all analytical procedures, equipment, reagents, chemicals, suppliers, facilities, technologies including establishing Repeatability / reproducibility norms, etc.
• Harmonization of systems and procedures across the site and designing systems for better documents control.
• Hands on experience in inspecting Quality plans, check lists, lab SOPs for conformance to standards and customer requirements
• Implementation of CQA guidelines and Quality Plan
• Proactively assess risk, plan and execute audit deliverables. Work with site team to ensure their systems are properly prepared for external and internal compliance inspections
• Reviews and resolves Quality issues /concerns with Plant Managers and others including Manufacturing, vendors and customers and with related functions. Coordinate and assist for vendor development
• Lead product quality risk management process and ensure right root causes and mitigation strategies are in place
• Provide expertise in critical quality areas of processes, Chemistry , Packaging, Regulatory and validations
• Lead all site Quality teams and train on customer orientation, stability studies of all FGs, hold up studies of WIP, Robust Root cause analysis of Internal OOS and Customer Complaints and designing and implementing effective /appropriate CAPA with finding out the effectiveness of the assigned CAPA.
• Drive Zero defects and right first time initiatives across the operations. Troubleshoot Quality issues in the manufacturing and packaging processes and perform CAPAs as necessary to reduce recurring problems through appropriate tools
• Providing training on GMP Compliances to manufacturing team.
• Keeping track by close monitoring of key quality attributes e.g. change controls, Deviations, Investigations, Complaints, OOSs etc.
• Qualification of Toll Manufacturing sites, that may be identified / defined in future
• Vendor Audits for Raw & Packaging Materials Suppliers.
• Implementation of ISO 9001 Quality Management Systems, as part of IMS certification in close co ordination with sites EHS.
• Work closely with EHS and cross function Site teams for success of various Audits such as TfS, Ecovadis etc.

Required Knowledge (of any equipment / Tools and techniques / Software)

• Proficiency in SAP usage
• Proficiency in Quality Tools like 7 QC Tools, Quality risk Assessment, SPC, FMEA etc.

Education & Experience

Education

Essential: Post Graduate in Chemistry

Preferred : Doctrate / Post Graduate in Chemistry

Experience

Essential: 7 to 10 yrs

Preferred:

Competencies / Skills

Essential:

• Ability to deal with complex quality analysis
• Comfortable working in an extremely dynamic environment
• A change leader in Quality who is highly flexible and able to quickly adapt to changing priorities
• Strong interpersonal skills with excellent oral and written communication skills
• A strong team-player with a passion to improve the product quality
• Organized and self-motivated
• Strong listening and influencing skills to foster an open, innovative and responsive environment and to drive change
• Promote and support an environment that encourages productivity, continuous improvements, teamwork, and a high level of professionalism

If you are interested for this position, kindly share your cv on below email id.

Email id: viddhi.kharwa@laxmi.com

Telephone no: 91-22-4910444-ext.513