Peddakotla Bala Chinna

Dynamic and results-driven professional eager to embrace new responsibilities and challenges that leverage and enhance existing skills. Committed to delivering exceptional performance through dedicated hard work and a proactive approach. Passionate about contributing to team success while continuously seeking opportunities for personal and professional growth. Prepared to make a meaningful impact in a collaborative environment.

• P. Bala Chinna
• Mobile: 9966116461
• E-mail: bchinna.pdk@gmail.com
• Dear Sir/Madam
• I have over 10 years of professional experience, currently serving as a Senior Executive in the Formulation ANDA department at Gland Pharma Pvt. Ltd., Hyderabad. As I seek to advance my career, I am looking to transition into a TTD role, where I can leverage my expertise in the pharmaceutical industry and contribute to the successful delivery of key projects.
• I have enclosed my detailed resume for your consideration. I am confident that, given the opportunity, I will not only meet but exceed your expectations, and work diligently to achieve the goals of the organization.
• Thank you for your time and consideration.
• Yours Sincerely
• P.Bala chinna

• Managing New Product Introductions: Oversee the handling and processing of new products from initiation to final batch production, ensuring all necessary steps are followed for smooth implementation.
• Coordination with Internal Departments: Collaborate with all relevant Heads of Departments (HODs) to ensure alignment on the macro-level activities of new batch processes, addressing any interdepartmental dependencies or requirements.
• Batch Coordination with Line In-Charges: Coordinate with production line in-charges to ensure all batch-related activities are carried out effectively, from preparation to execution, maintaining adherence to schedule and quality standards.
• Client Coordination: Communicate with clients at each stage of the batch production process, ensuring timely updates, addressing concerns, and meeting client-specific requirements from start to finish.
• Cleaning Verification Protocol Review: Review and approve cleaning verification protocols to ensure that all equipment is properly cleaned according to established standards before starting new batches.
• Cleaning Verification Compliance: Ensure that cleaning verification processes are followed for all equipment, including sample collection and analysis of results to guarantee adherence to cleanliness standards.
• Cleaning Verification Requirement Determination: Determine whether cleaning verification is necessary for specific batches (e.g., for API materials that are water-soluble) based on established criteria and production requirements.
• Dirty Hold Time Tracking: Responsible for monitoring and documenting dirty hold times, ensuring that bulk samples are collected and the associated results are tracked and reported accurately.
• Bulk Hold Time Sample Management: Ensure that bulk hold time samples are sent to the Quality Control (QC) department in a timely manner for analysis, and follow up to obtain results.
• Batch Completion Oversight: Take ownership of the batch completion process, ensuring that all activities are carried out smoothly, and any issues are addressed promptly to avoid production delays.
• Issue Escalation: Proactively escalate any production or operational issues to the appropriate supervisors, managers, or departments without delay, ensuring timely resolution and preventing operational disruptions.
• Process Validation Recommendations: Provide hands-on support for Process Validation (PV) recommendations, ensuring compliance with Standard Operating Procedures (SOPs) and the Quality Assurance (QA) department's guidelines.
• Batch Record Preparation: Prepare and organize batch records (BPCRs) to ensure complete and accurate documentation of all batch processes, in line with regulatory and internal standards.
• BPCR and CAPA Review: Review Batch Production and Control Records (BPCRs) and Corrective and Preventive Actions (CAPA) to ensure proper documentation and implementation of corrective actions for continuous process improvement.
• Change Control Management: Participate in and manage Change Control processes within production, ensuring that changes are documented, evaluated, and implemented according to company protocols.
• Change Control and BPCR Closure: Actively push the team to ensure timely closure of change controls and the preparation of BPCRs, minimizing delays in the production timeline.
• Material and Excipients Dispensing: Ensure proper dispensing of Active Pharmaceutical Ingredients (API) and excipients, adhering to correct procedures and maintaining compliance with storage conditions throughout the process.
• Storage Conditions Compliance: Monitor and verify that both API materials and finished products are stored under the appropriate environmental conditions, ensuring product integrity and compliance with storage requirements.
• Finished Product Storage and Packaging: Ensure that finished products are stored and packaged according to established guidelines, ensuring product safety, quality, and regulatory compliance.

• USFDA
• TGA
• Customer Audits
• ANVISA
• MHRA
• Other internal and external Audit

• Good team player.
• Hard working with commitment.
• Able to do work individually.

• PERMENENT ADDRESS:-
• House number:-12-12, Rasulpet, Phirangipuram
• Guntur DST, pin no:-522529.
• MARTUALSTATUS: - Married
• NATIONALITY: - India

I hereby declare that the above information is true for the best of my Knowledge and believe. 

Date:-

Place: - 

                                                                                                                     (P.Balachinna)