Manager - QA & QC

# LifeStyles Healthcare is hiring for New Talents #

Position : Manager – QA & QC

Position Reports to : Senior Manager - QA

Qualification : Degree in Science Discipline

Experience: 15 to 18 Years’ Experience in manufacturing sector from Pharma, Medical Device,

Latex products

Location : Jigani, Bangalore, Karnataka, India

Languages : English, Hindi, Kannada

Salary Range : 20 Lakhs INR / Annum

Job Description :

• Understand the quality systems documents, procedures, needs of various standards applicable to Suretex and make necessary changes as and when required. Ensure that documents are changed and updated in a controlled manner. Control of Documentation and distribution.
• Assist the Management Representative in preparing the annual plan for IQA to ensure that all the necessary clauses applicable for different Quality Standards are audited at a regular interval. Prepare IQA schedule at a regular interval as per the year plan and conduct the Internal audits.
• Co-ordinate with Internal Quality Auditors and document the IQA activities, findings and follow-up. Compile audit findings and report to Management representative. Also conduct the IQA audit as per allocated schedule.
• Follow-up for the effective implementation of all corrective / preventive actions taken from complaints, nun-conforming products, IQA's process icon-conformances etc. and reporting to MR.
• Assist the Management Representative in conducting the MRM and collecting the relevant information required for the meeting. Follow-up with the responsible person to execute the decisions/actions taken in the MRM.
• Review the DHR of the goods being released and ensure that the process was done in accordance with the specifications and procedures.
• Analyse the defects observed in the pre-dispatch test and report the findings to the respective department and Manager Q.A. for further action.
• Investigation, analysis and response to customer complaints / feedback with corrective actions.
• Coordinate to the respective region to get the post marketing samples and carry out the testing and analysing the data as per the scheduled intervals.
• Closely monitor the manufacturing process, in case of changes that occurred due to validations, process developments, design changes o\ new product development, assess the need for new approval and inform the assessment to Sr. Manager QA.
• In the case of the new 510 (K) approval, assist in preparing all the required documents to be submitted to USFDA.
• Understand the organization role with the notify bodies like USFDA, CDSCO, BSI, Drugs Control Department of Karnataka and others. Communicate with responsible persons of the notified bodies and update the necessary information required for the business.
• Understand the statutory requirements of National and International Quality Standards and Systems. Ensure that Suretex’ s quality system is in line with all the standards applicable to us. Maintain the quality system in such a way that external audits like USFDA, CDSCO, BSI, USAID, UNFPA, ANVISA, inspection by the authorities of Drugs Control Department of Karnataka, etc., ai e faced successfully in any point of time.
• Co-ordinate with the liaising person for the submission of application regarding the renewal of license, brand registration, free sale certificates and others if any with the local FDA/CDSCO.
• Co-ordinate with logistics team in getting the Order and verify the brand registrations are available for the order. Review the Incoming Materials test results, its decision. Review the MRB, CAPA and its closure.
• Review & approve the brand specification.
• To review & approve the certificate of analysis for all batches on completion of final release testing. Authorize Final release / dispatch after completion of certificate of analysis.
• Coordinate with external sampling / testing agencies for organizing inspection and forward samples as per requirements. Follow-up for the results. Compare the results of external lab and in-house results. Participating to inter lab trials, summarizing the findings and addressing the actions if any required.
• Follow up with the respective personnel for the initiation of material review board, change request, CAPA and document the same.
• Ensure that the activities are to be complete as per the schedules like Device Calibration, Testing, MRB closure etc.
• Ability to achieve respective Quality, Laboratory KPIs as per the targets.
• Aware Quality standard requirements such as ISO 9001, ISO 13485, USFDA QSR Part 820 and other applicable regulations.
• To take care and manage the overall laboratory activities, including the verification of work affecting the results of laboratory activities, such as review and release QMS, MR, etc.
• To ensure laboratory activities are carried out by impartially and the personnel of the laboratory, either internal or external, that could influence the laboratory activities shall act impartially and be competent.
• To keep confidential of all information obtained or created during the performance of laboratory activities, except as required by law.
• To Follow Safety, Health and Environmental procedures such as safe work practice, IS0 14001 activities, maintaining safety calendar and 5S activities on a monthly basis and to conform with the regulatory requirements, wherever relevant to the site.
• Should be aware of the EHS Policies & Procedures. Reporting of EHS activities /concerns /incidents /near miss and accidents. Reviewing the EMS Aspect & Impact analysis, Risk assessment etc.

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:

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