Job Title:  Assistant Manager-CDMO, Validation QA

ORGANISATIONAL OVERVIEW

We, Lambda Therapeutic Research Limited are a leading global Clinical Research Organization (CRO) headquartered in Ahmedabad – India, with facilities and operations in Mehsana (India), Warsaw (Poland), London (UK), Pittsburgh (USA), Las Vegas (USA) and Fargo (USA). Over 1500 employees are working across the globe in these facilities.

Lambda offers Full-spectrum clinical trial solutions empowered by more than 20 years of service to the biopharmaceutical and generic industry. At Lambda, our gamut of services under the clinical research domain are executed with comprehensive efforts, to deliver positive results. Led by a management team of highly qualified & experienced industry leaders, we apply innovative technologies, therapeutic expertise, and a commitment to quality to help clients develop products safely, effectively, and quickly.
Delivering the best accomplished by hiring the best. Employees are the pillars that hold up every quality promise that we make. That is why, we at Lambda are always looking for qualified and energetic individuals, with a desire for excellence, to join our team.

JOB DETAILS

• Will be responsible for review of all different Qualifications/Validations, Requalification & Facility Assurance documents. Preparation of SMF, VMP and other Quality Assurance department related documents.
• Will be responsible for review of records maintained by the Warehouse, Production and Engineering team, conducting all documentation with respect to Quality Assurance (QA) activities, ensuring that documentation is happening online, and follow the QMS reporting system in the case of deviations.
• Will be responsible for issuance, availability, and adherence of approved procedures to the manufacturing team.
• Will be tasked with checking the adherence to the Quality Management System (QMS) elements, such as change control, incident management, and CAPA (Corrective and Preventive Actions) management on the shop floor.
• Responsibilities also include verifying whether the manufacturing facility meets basic Good Manufacturing Practice (GMP) requirements at all times, including facility upkeep, environmental conditions, segregation of materials, and status labelling. In case of deviations, you will follow the QMS process.
• To provide essential support to the supervisor in conducting investigations related to complaints, batch failures, Out-of-Specification/Out-of-Trend (OOS/OOT ) results, incidents, etc. by collating data and conducting interviews.
• Will coordinate with cross-functional teams to facilitate and drive the investigation process, conduct a thorough root cause analysis, document CAPA, verify implementation within the agreed timeline, and monitor its effectiveness over time.
• You will be responsible for supporting or assigning personnel to assist in internal and external audit activities, following the instructions of superiors, providing necessary information, documents, and clarifications to supervisors during actual audits, and maintaining appropriate records.
• You will follow up with respective user departments to share audit responses and diligently track and maintain the closure of action items arising from audits as needed.

EXPERIENCE

• 7 to 10 years of work experience in quality assurance department of a biopharmaceutical or relevant company

EDUCATIONAL QUALIFICATION

• MSc in Biotechnology/ Biochemistry/Microbiology.
• M.Pharm in Quality Assurance