Quality Assurance Professionals (Sr. Officer to Sr. Executive) – Injectable Operations
Windlas Biotech Limited is actively seeking experienced Quality Assurance professionals to join our dynamic team.
Company Overview:
Windlas Biotech Limited is a leading pharmaceutical company committed to delivering high-quality healthcare solutions. With a focus on innovation and excellence, we operate state-of-the-art facilities and foster an environment where dedicated professionals can thrive. We are expanding our team and seeking individuals who are passionate about maintaining the highest standards of quality in pharmaceutical manufacturing.
About the Opportunity:
We are currently recruiting for skilled Quality Assurance professionals at the Sr. Officer to Sr. Executive levels, specifically within our Injectable Operations department. This is an excellent opportunity for individuals with a robust background in pharmaceutical QA to contribute significantly to our quality systems and operational excellence. The role is based at our advanced facility in Mohabewala Industrial Area, Dehradun, Uttarakhand, offering a challenging yet rewarding career path.
Key Responsibilities:
As a vital member of our Quality Assurance team, your responsibilities will include:
- Thorough review of critical documentation, including calibration, preventive maintenance, qualification, validation, and engineering records.
- Coordination and oversight of utility/facility qualification processes for essential systems such as AHU, compressed air, chiller, boiler, and water systems.
- Active involvement in Process Validation and Cleaning Validation activities to ensure compliance and effectiveness.
- Managing In-Process Quality Assurance (IPQA), Validation Master Plan (VMP) adherence, Standard Operating Procedure (SOP) preparation, temperature mapping, and Computerized System Validation (CSV) tasks.
- Analyzing quality trends and providing support for systems like LIMS (Laboratory Information Management System), ERP (Enterprise Resource Planning), TQAs, and QMS (Quality Management System) activities.
- Conducting detailed investigations into deviations, discrepancies, and failures, utilizing Root Cause Analysis (RCA), Corrective and Preventive Actions (CAPA), Change Control, and risk assessment methodologies.
- Assisting with internal and external audits, as well as the preparation of Annual Product Quality Reviews (APQR).
- Overseeing comprehensive document control, including the issuance and archival of Batch Manufacturing Records (BMR) and Batch Packaging Records (BPR), alongside efficient record-room and sample-management operations.
Qualifications & Experience:
- Educational Background: B.Sc., M.Sc., B.Pharm, or M.Pharm from a recognized institution.
- Experience: 5 to 8 years of relevant experience in Quality Assurance, specifically within Injectable Operations in the pharmaceutical industry.
Location:
Mohabewala Industrial Area, Dehradun, Uttarakhand
How to Apply:
Interested and qualified candidates are invited to share their updated CV and cover letter.
Email your application to: hr@windlasbiotech.com
For further inquiries, you may contact us at: +91 8279415146 or +91 9760276274
