Company Overview

Job Description

We have the following opening with one of our clients, a leading Lozenges Mfg. Pharma company. Post: Manager – QA No. of posts: 1 (One) Location: Hubli Package offered: Attractive package, not a constraint for the right candidate. Present package should be between 10 LPA & 12 LPA. Experience: 12 to 15 years in Tablets / Capsules of a Pharma company, basically pharma background with OSD. Education: M.Sc / B. Pharma / M.Pharma. Job Description: • To perform the Gemba Walk in all the departments to ensure continuity of cGMP compliance and implementation of data integrity principle. • In absence of Head QA, authorized to look after overall activities of QA Department. In case quality critical activities such as deviation / OOS assessment, Head QA shall be consulted before approval. • To ensure that CAPAs are taken against the failures/ non-conformities/ complaints, implemented, tracked for implementation and monitored for its effectiveness. • Imparting the training to the all the cross functional departments on updated guidelines and SOPs. • To assist / guide the team for timely preparation and review of Annual Product Quality Review, Water / Compressed air trends etc. • To assist / guide the team for timely preparation and review of process validation protocols / reports, cleaning validation protocols / reports and review of analytical reports. • To prepare, review the equipment qualification protocol/report and to monitor the qualification activities. • To ensure that raw and packing materials are received at site from only approved and qualified vendors. To approve the qualification of vendor as per the procedure. • To ensure the SOPs are in place for all the activities / operation in all the department and are reviewed / revised timely. To review and update the systems and documents including the SOP’s according to updated guidelines. • To administer day-to-day documentation team activities such as issuance of necessary documents / forms to all departments for carrying out regular activities, retrieval and archival of documents. • To ensure that validations / revalidations of processes/ procedures are carried out as per validation master plan. • To ensure that risk assessments of various activities being performed as per the need. • Responsible for review and approval of various documents such as SOPs, protocols, reports, specifications, batch records and other quality system documents etc. • To ensure that deviations, failures, market complaints and OOS results are reported and properly investigated to establish the root cause and adequate actions taken to avoid the re-occurrence. • To ensure that changes are proposed, evaluated, implemented and closed in timely manner. • To ensure that self-inspection of all the departments is carried out as per the schedule and appropriate actions are taken to comply the non-compliances. • To review the trend reports of environmental /water / stability reports and suggest actions if required. • To approve art works and shade cards of all printed packaging materials. Immediate joiners or within 15 to 30 days are preferred. Suitable and interested candidates kindly email your CV to cs@pepcs.in along with your present / last drawn CTC and notice period details immediately. Also register your profile with our job portal https://www.careerheights.in/sign-up.php. Reach us on 8374741972 for more details. Recruitment agencies kindly excuse. Skills: SOP, GEMBA, cGMP, CAPA, Quality review, protocol, Lozenges..

Required Exp

12 to 15 years yrs

Skill Required

Quality Assurance, QA, SOP, GEMBA, cGMP, CAPA, Quality review, protocol, Tablets, Capsules

Job Location

Hubli, Karnataka

Salary Package

$ 15,00,000

Date of Job Posting

2024-03-20 10:28:11