Associate Manager - MQA upstream

Pfizer; Visakhapatnam; On-site; INR 900,000 - 1,500,000; Full time

Job summary

Pfizer in Visakhapatnam, India seeks an experienced Manufacturing Quality Assurance professional to ensure cGMP compliance across Solution/Emulsion preparation, washing, Depyrogenation, Filling, Capping and Collection operations.

You will review eBRs, AMPS exceptions, batch reports and audit trails, perform trend analysis, and ensure SOP conformance. 6–10 years in pharma QA and a B.Pharm/M.Pharm/M.Sc. are preferred.

Qualifications

• Preferred Education/ Qualification: B. Pharma / M. Pharma / M.Sc.
• Experience: 6-10 years in Manufacturing Quality Assurance / Production at a pharmaceutical facility.
• Knowledge of cGMP, regulatory compliance, and QA processes.

Responsibilities

• Ensure operating state of cGMP compliance in Solution/Emulsion preparation, vial/ampoule washing, Depyrogenation, Filling, Capping and Collection operations.
• Maintain regulatory compliance in accordance with cGMP practices.
• Ensure manufacturing policies and procedures conform to Pfizer standards.
• Review eBR (Electronic Batch Record) and assess AMPS exceptions with supervisor input.
• Review of batch reports and equipment audit trails.
• Perform Alarm impact assessment, review and approval of trend reports.
• Ensure start-up and in-process activities performed as per batch record and SOPs.
• Monitor adherence to manufacturing practices and procedures.
• Perform CCTV monitoring to oversight activities in manufacturing process area.
• Daily walk-throughs per clean room behavior and report observations to supervisors.
• Troubleshoot manufacturing area to support quality and patient safety.
• Lead investigations and CAPA closures when required.
• Assist investigators with data collection and technical support.

Skills

Fundamental knowledge of manufacturing

Regulatory inspections knowledge

Technical writing

Education

B.Pharm / M.Pharm / M.Sc.

Job description

Roles and responsibilities:

• Responsible for ensuring operating state of cGMP compliance in Solution/Emulsion preparation, vial/ampoule washing, Depyrogenation, Filling, Capping and Collection operations.
• Maintain regulatory compliance in accordance with cGMP practices.
• Ensure manufacturing policies and procedures conform to Pfizer standards.
• Knowledge and hands on experience in reviewing eBR (Electronic Batch Record) and assessing the impact of AMPS (Agile manufacturing production system) exceptions with technical support/inputs from supervisor.
• Review of batch reports and equipment audit trails.
• Perform Alarm impact assessment, review and approval of trend reports.
• Ensure start-up and in-process activities performed as per batch record and compliance to Standard Operating Procedure.
• Monitor and adherence manufacturing practices with respective standards and approved procedures.
• Perform CCTV (Close Circuit Television) monitoring to oversight the activities in manufacturing process area.
• Perform daily walk throughs as per clean room behavior/Coaching program and report observations to the supervisors and ensure appropriate closer of those incidents.
• Perform equipment breakdown assessments and ensure product quality and patient safety independently.
• Report any non-compliance to the supervisor.
• Responsible for performing manufacturing investigations, implementation and approved investigation CAPA
• undefined
• Manage investigation and apply relevant and necessary actions/ systems to ensure appropriate closure of those incidents.
• Have trouble shooting abilities in manufacturing area, which helps the organization to develop, implement and achieve its mission, vision and values.
• Identify gaps and involve in process and procedure simplification, thereby reduce downtime and increase the efficiency.
• Experience in handling regulatory, corporate and internal auditors / inspectors.
• Responsible for assisting manufacturing investigators for collection of data, information and technical support and may perform in conducting investigations.
• Ensure that reports are aligned with regulatory requirements, site standards procedures and company policies.
• May lead a team of MQA colleagues on an interim basis in the absence of the Supervisor.

AMPS: (Agile manufacturing production system)

• Review and approval Master recipes.
• Review and approval of Master workflows.

Review and approval of Master data (Graphs, Classes, Entities.).

Cultural Attributes:

All Pfizer colleagues and contingent workers are expected to conduct themselves in line with the Pfizer Values; Courage, Equity, Excellence & Joy

Statutory Obligations:

All colleagues and contingent workers are expected to conduct themselves in line with relevant legislation pertaining to workplace health and safety, discrimination, harassment and bullying.

Environmental Health and Safety:

Participate in and take responsibility for workplace environment, health and safety at the level required for this position, following the guidelines in the company Environmental, Health and Safety Management System Manual.

Here Is What You Need (Minimum Requirements)

• Preferred Education/ Qualification B. Pharma / M. Pharma / M.Sc.

• Experience6-10 years experience in Manufacturing Quality Assurance / Quality Assurance/ Production of a pharmaceuticals manufacturing facility.

Core Competencies:

• Fundamental knowledge of manufacturing process
• undefined Have capable of handling regulatory inspections USFDA (U.S. Food and Drug Administration) / MHRA (Medicine and Healthcare products Regulatory Agency) / TGA (Therapeutic Goods Administration) etc.,
• Technical writing - Ability to create documentation that is accurate, complete, unambiguous, an Concise as possible aimed to be understood by any level of organizations. Knowledge of various quality tools required for investigations

Standards, Processes & Policies

• GMP and regulations governing manufacturing operations for sterile products.
• Adhering to site procedures and corporate policies.

Bonus Points If You Have:

Advanced Competencies

• Interpersonal Skills: Effective communication with all staff from different levels and builds constructive and effective relationship.
• Acts Decisively: Makes decisions in a timely manner based on available information.
• Written communication: Ability to write in a timely manner based on available information.