Senior Team Leader - Manufacturing compliance

Pfizer Healthcare India Private Limited - Vizag

10 - 15 years

10 - 16 Lacs

visakhapatnam

Posted:8 hours ago| Platform:

Apply

Skills Required

capa change control qms quality management systems manufacturing compliance quality risk assessment safety system data integrity market complaints audit compliance ccf gmp pdocs usfda audits mmr sop quality cgmp alcova deviation quality systems

Work Mode

Work from Office

Job Type

Full Time

Job Description

Be responsible to lead downstream manufacturing compliance.
Ensure quality management systems in line with cGMP and regulatory requirements and handling training requirements
Handling Change control management system including CCF impact assessment, preapproval, cross functional CCF evaluation, monitoring of closure of change controls and change control action item.
Coordinate with investigator in identifying appropriate CAPA and tracking for closure of the CAPA.
Responsible for the review and approval of Master manufacturing records for the commercial batches.
Responsible for review and approval of scale up, exhibit, intended and Process validation master manufacturing records.
To review and approve the quality risk assessment for the equipment and process.
Responsible for compliance to audit observation, tracking and implementation of audit commitment action items
Monitoring training metrics on daily basis for all the production employees with on time training without past dues.
Continue to ensure stock availability of all consumable material for production.
Responsible for review of compendial assessments.
Responsible for the review and approval of trends and APQR.
Responsible for the review of SQRT slides for the trends.
Coordinate with QA documentation and production for issuance and retrieval of document to and from production.
Support site inspection readiness program in providing updating on commitment tracking action items to Production leadership team and QA.
Perform regulatory observation network assessments gap assessment for manufacturing process and system at Vizag site and implement identified gaps.
Review and approval of documents in PDOCS
Coordination and monitor training metrics for timely completion of production colleagues and contingent worker training.
Implement cGMP and ensure compliance of SOPs, Quality Systems, Safety Systems and Pfizer policies at all stages of activity
Participate in regulatory, corporate and internal inspections
Support in development of responses to market complaints and implement corrective actions
Support investigation, identify root causes and suggest CAPA
Review and approval of change control
Review, approval and finalization of deviations
Recognizes development needs and identifies/creates development opportunities (e.g., special assignments) for colleagues within own functional area
Develops a talent base and anticipates development needs within the area of responsibility
Manages performance of direct and indirect reports and support functions / area objectives through goal setting, ongoing assessment and coaching and performance evaluation.
Engage and inspire the team on performance expectations and coach the team to meet those expectations using Coaching Skill principles

More Jobs at Pfizer Healthcare India Private Limited - Vizag

Manager - Operational Excellence

Visakhapatnam

10.0 - 15.0 yrs

INR 20 - 30 Lacs

Group Manager - Visual inspection (Injectables)

Visakhapatnam

10.0 - 20.0 yrs

INR 15 - 25 Lacs

Experience operators For Manufacturing roles

Visakhapatnam

1.0 - 6.0 yrs

INR 2 - 6 Lacs

Walk in Drive -Manufacturing - Senior Equipment Specialists (SES) Role

visakhapatnam

6.0 - 10.0 yrs

INR 6 - 10 Lacs

Senior Team Leader - Manufacturing compliance

visakhapatnam

10.0 - 15.0 yrs

INR 10 - 16 Lacs

Mock Interview

Practice Video Interview with JobPe AI

Start Job-Specific Interview

Start Your Job Search Today

Browse through a variety of job opportunities tailored to your skills and preferences. Filter by location, experience, salary, and more to find your perfect fit.