Job Description
What You Will Achieve
You will be a member of Pfizer s dedicated and highly effective quality assurance team. You will evaluate and review Pfizer s clinical and commercial batches of drugs. You will make sure that product and process documents match the specifications based on established sampling and statistical process control procedures. Your expertise will help in identifying deviations from established standards, in the manufacturing and packaging of products. In the relevant cases you will approve investigations and change control activities to ensure compliance with configuration management policies.
As an associate, your focus on the job will contribute in achieving project tasks and goals. Through your domain knowledge and commitment, you will create a collaborative teaming environment for your colleagues.
How You Will Achieve It
Batch Manufacturing Record Review. Control Sample inspection storage as per label storage condition data entry in caliber LIMS. Review of Environmental Monitoring records. Review of applicable Change Controls Investigations related to batches to be released. Compilation of data for Annual Product Review. Visual Inspection of Control Sample as per defined frequency. Tracking completion of CAPA commitment. Preparation review of SOP s applicable to job function. Maintain individual ITP as stated in the objectives.
Management of Product Complaints. Coordinate the investigations at site Tracking of associated gQTS activities. Management of the Annual Product Review System. Management of investigations.
To identify, prepare, review, update training related SOPs and implement them on approval.
To prepare annual master Training plan in consultation with all HODs, HR dept and monitor its implementation.
To prepare monthly Training Plan/schedules and coordinate its implementation.
To coordinate General Orientation programs for New recruits with HR respective Trainers
To conducts cGMP induction training to designated employees.
To conducts spot audits, provides reports for feedback, observations to concerned HODs /Supervisory Management and monitor Training effectiveness/evaluation there from.
To ensure receipt of appropriate training documents and enters, updates, maintains Training Records in Learning Management System and furnishes Training related information and records to concerned individuals.
To coordinate with Heads of Dept, development/updating of Curriculum for all the positions and ensure compliance with SOP in this regard.
To track compliance of Training schedules, such as General Orientation, Departmental Orientation.
To deliver Train the Trainer program, for employees.
To conduct SOP training on training related SOPs to designated employees, perform assessment and training documentation thereof.
To plan and organize for cGMP reinforcement and specialized cGMP training modules as required and ensures participation of designated personnel for the programs
To review specific deficiencies in Training requirements by reviewing deviation reports, internal audit reports, external agency observations, etc.
To develop and implement a system for receipt. Storage, issue recording, retrieval, achieving, copying, distribution of controlled Documents to user departments and reconciliation thereof.
To prepare SOPs, reviews for biannual review and Training outlines
Qualifications
Must-Have
- Bachelors Degree in Pharmacy
- 2 to 4 years experience in pharmaceutical industry
- Experience in Quality Management Systems
- Sound knowledge of current Good Manufacturing Practices {part of GxP}
- Ability to work in a team environment within own team and interdepartmental teams
- Effective written and oral communication skills
Nice-to-Have
- Experience at a manufacturing site
- Experience of writing and managing deviations
- Experience in production batch record review, Enterprise Resource Planning system, investigation of non-conformance, root cause analysis and change control management