Titan Laboratories Pvt. Ltd Job Opening For QA Manager

Titan Laboratories Pvt. Ltd Job Opening For QA Manager

Education

B.Pharma in Any Specialization

Experience: 12 - 17 Years

Work Location: Raigad

Designation: QA Manager- Mahad, (Only Male)

Job Description

Note: B. Pharm ( Mandatory) from Finished Formulations Background with good Leadership Quality

Share CV on Shivali.k@titanpharma.com

JD:

Managing a team persons direct reportees.

Spearheading the entire functions of quality management and regulatory approvals, regulatory query related to dossiers support, CAPA preparation and compliance of regulatory audits and employee training on cGMP & guidelines

Supervising the activities like training need identification, arranging external training, selection of trainer and maintaining the schedules as per training plans

Maintaining the GMP level as per regulatory requirement every time and ensuring submission of executed batch documents of exhibit & validation batches to the RA

Liaising with regulatory department for quarries or document related requirements

Monitoring the effective implementation of best manufacturing practice & QMS

Reviewing SOPs, SMF, VMP, Quality manual, HVAC manual

Conducting departmental training & internal audits

Verifying annual product review report

Planning stability study & preparing protocols as per ICH guideline Developing protocols and reports for validations and qualification

Led the training program (GMP & On Job Training), self-inspection, BMR/BPR preparation, APQR, equipment qualification, heating ventilation and air conditioning system validation, water system validation & facility qualification

Managed the entire functions of quality management & regulatory approvals, training related to cGMP, incident investigation, change controls, deviations including non-conformities

Trained employees on basic cGMP, risk assessment and quality systems

Reviewed and approved process validation protocols, reports & functional SOPs