SCL Lifesciences Ltd (SCL)

Roles and Responsibilities For IPQA BMR review. To ensure the line clearance to the production unit. To ensure all QA activities are carried out as per the Standard operating procedure. Issuance, Retrieval, Approval & Controlling of all Quality related Documents (i.e. CSOP, SOP, STP, GTP, Protocol, etc.) Preparation, Review, and Retrieval of SOP. Candidate must have relevant experience in IPQA API Industries. Should have good communication and interpersonal skills. For QMS Direct involvement in Deviation and Process Investigation. Handling of Change Control, Process Validation, Qualification, APQR, and Trend Report. Handling Market Complaints, Audit Compliance Reports & QMS-related activities. Fundamental knowledge about the investigation process. Review site compliance reports as applicable and follow-ups for adequate closure through appropriate supporting documents and addendum reports from the site. Trending & evaluation of observations for management notification Identify specific areas of improvement based on emerging trends and provide/organize training to the site as and when required. Data collection, trend QMS data, and establishing emerging trends. Preparation of department SOP & Corporate policies/SOPs, as and when required. Assist in regulatory or external inspections for site readiness. To discuss the gaps identified during the review with the site SME / QA Head / CQ Lead for resolution. Desired Candidate Profile Candidate must have relevant experience in QMS or IPQA - API Industries Should have good communication and interpersonal skills.