Senior Manager

4 weeks ago

Delhi, India LifeStyles Healthcare Full time
# LifeStyles is currently looking for new talents #”

Job Description:

Position: Senior Manager – Quality Assurance

Position Reports to: Director – Quality Assurance

Downline Reporting: Manager – QA, Associate Manager – QA & QC, Manager – in Process QC, Associate Manager – QA & RA, Executives, and Junior Executives.

Location: Plant – Bangalore, Karnataka, India

Job Responsibilities:

To work and act as E2E quality leader for assigned manufacturing site.The role requires a high degree of working independently and remotely with a wide range of stakeholders across several regions while still maintaining core focus on driving site deliverables.To establish Quality Management Systems and ensure its implementation in coordination with Global functions.To function as the Management Representative at the Site for maintenance of the Quality Management System.To ensure awareness of Regulatory and Customer requirements.To plan, resource, develop and manage all the facets of Quality Assurance activities, including Laboratory and In-process QC and Regulatory Affairs, Quality systems, their documentation, review and reporting.To coordinate External / Internal audits and review and ensure effective implementation of Corrective actions.To review specifications, Quality Plans and test methods and ensure that they are followed and improve them as required.To review and authorize finished goods release and ensure finished goods are tested on time, as per the relevance standard, Customer specification and regulatory requirements.To review Quality Trends at Plant and initiate Corrective & Preventive Actions for any deviation occurs and review their effectiveness and approve it.To ensure outgoing Quality trends are achieved as per the targets.To ensure that Regulatory requirements such as ISO 13485, ISO 17025, USFDA QSR part 820, Medical Devices Regulations, Medical Device Rules, MDSAP etc., regarding manufacturing of Medical Devices are implemented and liaise with Regulatory agencies.To review and approve Deviations, NCR’s, CA-PA, Change Control activities.To review and approve procedural changes arising out of protocols and Validations.To ensure effective handling of Customer Complaints, investigation, Corrective and Preventive Actions, responses and improvement to product quality and quality systems.To review Supplier Audits in association with Logistics and ensure Quality of incoming materials as per the specification and process requirements.Conducting Supplier Audits. Review and approve the Supplier audit reports.To undertake development projects in improving product and process quality and in implementation of quality systems.To identify the training needs of quality team in their functions and ensure that the personnel are trained, and their competence meets and requirements.Such other assignments the Management may be given from time to time.Report of Quality issues encounter in the Plant, seek advises on issues that cannot be resolved by Plant get the guidance from Quality Director and, related to Regulatory Affairs activities get the guidance from Director – Global RA.Give the feedback to General Manager (Plant) and Quality Director for Quality performance, Complaint trend, resources requirement for effective implementation of the Quality system on regular basis.Motivate subordinates so as to achieve the Company targets, KPI.Monitor the Key Performance Indicator (KPI) for the company and report Quality Performance to Management.Able to work as a team player, involved in the improvement project team to assist in improving quality, optimizing process efficiency and ensure compliance to Regulatory affairs.To interface effectively with all functional areas whenever is necessary and provide technical expertise and assistance to ensure improvement are conformed to regulatory requirement.This job responsibility is subject to change by the Management to suit changing requirements from time to time.This does not restrict Management’s right to change assignment under its Job rotation policy to suit Company’s requirements and / or individual’s growth opportunities.Aware the Environment Management system and implement in the department.Safety awareness programme shall demonstrate to the subordinates and ensure that the team should following the safety precautions during their work.

About the Company

LifeStyles has a history dating back to 1905

when Eric Ansell first started making condoms in Richmond Australia.

Today LifeStyles is a Global leader in the sexual wellness sector, comprising a broad range of condoms, personal lubricants, and other related products and other products in over 60 countries.

Owning a large portfolio of trademarks, LifeStyles manufactures and commercialises its products either under leading global non-latex condom brands SKYN® under its local heroes such as LifeStyles®, Manix®, Unimil®, and Blowtex® and Control®.

Outside of branded products, the Company also supports universities, NGOs, and other organizations as part of a broader effort to promote sexual health and prevent the spread of STDs and STIs. LifeStyles owns and operates manufacturing facilities in Thailand, India and Spain, and it employs over 1,600 teammates globally.

LifeStyles Healthcare was created on September 1, 2017 , when the consortium of Humanwell Healthcare & CITIC Capital private equity purchased the Sexual Wellness division from Ansell.

As of December 1, 2022, Lifestyles is owned by Linden Capital Partners , a Chicago-based private equity firm focused on the healthcare industry.

This is an exciting time to join us. We combine century-long history with the opportunity of a new beginning as a stand-alone company - this means a new way of thinking, the opportunity to explore new horizons and the chance to make a mark in an exciting, fresh business.

LifeStyles Healthcare is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.

We are empowered professionals, and we are committed to creating a team of the world’s

“best of the best.”

Our business foundation is strong, among our values are Integrity and Respect, our people are highly engaged, and we are excited about a new phase in the company history. We have a focus on safety and teamwork - and we want you to join us

All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

Discover more about us at:

.Curious to know what does every day look like at LifeStyles?Find out by looking at employee testimonials:

to the high number of applications, we would like to inform you that only selected candidates will be contacted.

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