Associate Manager - MSAT Validation
- Pfizer
- 3 - 6 years
- Visakhapatnam
- 2 days ago
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Job Description
Use Your Power for Purpose
Every day, Pfizer s unwavering commitment to quality ensures the delivery of safe and effective products to patients. Our science and risk-based compliant quality culture is both flexible and innovative, always putting the patient first. Whether you are involved in development, maintenance, compliance, or research analysis, your contribution directly impacts patients.
What You Will Achieve
In this role, you will:
- Evaluate and review clinical and commercial drug batches to ensure compliance with established specifications.
- Conduct rigorous sampling and statistical process control procedures to identify deviations from standards.
- Approve investigations and change control activities to maintain compliance with configuration management policies.
- Contribute to moderately complex projects, managing time effectively and developing short-term work plans.
- Independently assess Change Control activities for potential Quality and Operational Good Manufacturing Practices (cGMP) impacts.
- Investigate and document Quality Assurance deviations, escalating issues to the Quality Assurance Lead as needed.
- Ensure regulatory compliance with current Good Manufacturing Practices (GxP) and provide Quality Review and oversight of site documentation to meet global regulatory and Pfizer quality standards.
Here Is What You Need (Minimum Requirements)
- High school diploma (or equivalent) with 8+ years of experience or associate s degree with 6+ years of experience or BA/BS with 2+ years of experience or MBA/MS with any years of relevant experience
- Solid understanding of current Good Manufacturing Practices and relevant GxP regulations and standards
- Strong critical thinking skills
- Ability to work effectively within own team and interdepartmental teams
- Good working knowledge of Microsoft Excel and Word
- Proactive approach to problem-solving
Bonus Points If You Have (Preferred Requirements)
- Experience in quality administered systems
- Strong organizational skills and attention to detail
- Experience with regulatory compliance and documentation
- Ability to mentor and review the work of other colleagues
Preferred Education/ Qualification :
- B. Pharm/ M. Pharm/ M. S (Pharmacy)/ M. Sc/ BE
Experience:
- 6 + years of experience in validation function of sterile dosage form facility.
Core Competencies :
- Understanding of pharmaceutical manufacturing, packaging, quality assurance, and quality control operations.
- Knowledge of validation principles and practices related to the following areas: manufacturing process, analytical method, cleaning methods, facility, equipment, instrument, utility system, and CSV systems.
- Conversant with design & working principles of key equipment used in sterile manufacturing -Autoclave, Vial washing, Heat tunnel, Homogenizers, Vail filling, Filter integrity testing devices, Visual inspection equipment, Packing equipment, and Cleaning Validations.
- Well versed with Terminal process - design, execution and review.
- Experience in plant and TS operations.
- Good document review skills, data analysis with ability to identify issues and recommend actions
- Knowledge on the Qualification instruments and Tools.
- Knowledge on the GAMP requirements, PDA guidance, ISO guideline, 21 CFR part 11.
- Knowledge on the Components level assessment, PM requirement.
- Good knowledge on the Validation instruments calibration.
- Knowledge on the assessment of the Change controls and failure investigations.
- Knowledge of current validation regulations in the industry and validation principles.
- cGMPs and FDA regulatory guidelines.
- Strong Technical skills, leadership, organizational planning and project management skills, in addition to strong technical background required to coordinate multi-disciplinary teams.
- Strong interpersonal skills.
- Excellent interpersonal effectiveness and communication skills (written and oral) to interface across departments and management levels.
Work Location Assignment: On Premise
Quality Assurance and Control
#LI-PFE
Job Classification
Industry: Pharmaceutical & Life SciencesFunctional Area / Department: Production, Manufacturing & EngineeringRole Category: ManagementRole: Manufacturing Operations ManagerEmployement Type: Full timeContact Details:
Company: PfizerLocation(s): Visakhapatnam
Keyskills: Process design Data analysis Manager Quality Assurance ISO Manufacturing process Analytical Pharma Configuration management Packaging Manager Quality Control
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