Junior Executive - Quality Assurance

Position: Junior Executive – Quality Assurance

Position Reports to: Senior Manager - Quality

Department: Quality

Location: Jigain, Bangalore, India

Qualification: B.sc or M.sc

Experience

Job Responsibilities:

• Ensure no injuries at workplace, Follow Safety, Health and Environmental procedures such as safe work practice, IS0 14001 activities, maintaining safety calendar and 5S activities on a monthly basis, reporting of EHS activities / concerns / incidents / near miss and accidents.
• Ensure the GMP practices in the workplace and maintenance the laboratory equipment and premises. Involve and co-operate in the implementation of best practices initiatives.
• Should be aware of the Quality Policy, Quality Objectives, EHS Policies & Procedures. Understand the Quality Management Systems requirements and aware of MDSAP, ISO 13485, 21 CFR part 820 and other applicable requirements.

Document Management & Control

• Establish and maintain a document control system to manage records efficiently.
• Ensure proper classification, storage, and retrieval of documents (physical and digital).
• Maintain version control and track document revisions.
• Manage confidential and sensitive information securely

Document Review & Approval Process

• Coordinate with various departments to review, update, and approve documents.
• Ensure documents follow the correct approval workflows and meet formatting standards.
• Track and follow up on pending approvals.

Document Distribution & Access Control

• Ensure authorized personnel have access to necessary documents.
• Distribute updated documents to relevant stakeholders as required.
• Prevent unauthorized access, changes, or loss of important records.

• Maintain the approved Procedures, distribution of the Procedures and Maintain the Master list.
• Assign the Validation Protocol, Stability Protocol, Deviation Note, CARs, AARs etc numbering and maintain the records.
• Prepare the monthly status on the Change Control, Deviations Note, CARs, MRBs, AARs etc. and communicate to Sr. Manager – QA.
• Update the Closing Status of Change Control, Deviations Note, CARs, MRBs, AARs etc. and communicate to Sr. Manager – QA.
• Update the Master List, Validation list, Stability Study list, Deviations Notes, In-Process CARs, Audit Action Records etc.
• Prepare the required reports as guided by the Sr. Manager – Quality.
• Maintain the Obsolete copies for easy traceability.
• Involve during Process validation for review the process and collection of samples for testing and Stability testing.
• Involve the Process Validation and Stability activities and update the prepare the report.
• Issue In-process CARs, MRB, Deviations as applicable and follow-up on the actions implemented and their effectiveness in the process areas.
• Ability to achieve respective Quality KPIs as per the targets.
• Plan and Initiate the Purchase Request for the required Materials for in-process and QA activities.
• Follow-up for the effective implementation of all Corrective actions taken from complaints, non-conforming products and reporting to MR.

About the Company

LifeStyles has a history dating back to 1905

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

As of December 1, 2022, Lifestyles is owned by Linden Capital Partners

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.

“best of the best.”

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: https://www.linkedin.com/company/lifestyles-healthcare/.

Curious to know what does every day look like at LifeStyles?

Find out by looking at employee testimonials: https://lifestylesglobal.com/careers

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