Job Title:  Assistant Manager AQA

ORGANISATIONAL OVERVIEW

Lambda Therapeutic Research Ltd. is positioning the “Contract Development & Manufacturing Organization (CDMO)” in its vision to serve as an integrated solutions provider for biologics drug development, GMP manufacturing, and to enable First in Human (FIH) clinical trials globally.Our flexible capacity and equipment trains, combined with our agile, collaborative approach, give us the ability to scale up any biologic product for each unit operation – from pilot batch to clinical quantities – to accelerate the time to file and market.In this integrated offering, the following cutting-edge technical functions will be fully engaged in providing end-to-end support to our customers in bolstering the development pathway for their lead biologics/bio-therapeutics or biosimilars, ensuring quality, precision, and success.

JOB DETAILS

• Will be responsible for review of test records, electronic audit trail’s log books, method development, method validation, Stability test records and reports.
• Will be responsible for review of records maintained by the Analytical Development Laboratory and Quality Control Laboratory,  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 Analytical Development and Quality Control 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 Analytical Development and Quality Control laboratory meets basic Good Laboratory and 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 years of industrial experience with specific operational experience in Manufacturing, Quality Control, Quality Assurance or Engineering & Development

EDUCATIONAL QUALIFICATION

B.Pharm. or Post-Graduation (Microbiology/Quality Assurance/Biochemistry/Biotechnology)