Greetings from Hetero!!
We are hiring for the position of Executive/Sr.Executive-Quality Assurance(IPQA) for Hetero Plasma Sciences, Hyderabad.
If you are interested or know someone who might be a good fit, please share the profile with us at Saiharish.M@hetero.com
- Qualification:- M.Sc-Chemistry/B.Pharmacy
- Exp Required:- 03-07Years
Key Responsibilities: –
Ø Perform and monitor In-Process Quality Assurance activities during the manufacturing process.
Ø Responsible for performing line clearance activities at various manufacturing stages and monitoring cleanroom behavior and aseptic practices.
Ø Verify in-process samples for quality testing and ensure the accuracy of test resultsduring different stages of manufacturing.
Ø Review and verify documentation related to manufacturing processes (BMR, BPR, GMP records for accuracy and completeness.
Ø Regularly inspect and assess manufacturing operations to ensure compliance with quality standards, cGMP, and established procedures.
Ø Responsible for preparation and review of Standard Operating Procedures (SOPs).
Ø Ensure adherence to cGMP and GDP requirements during document preparation and review.
Ø Ensure all IPQA activities comply with SOPs and Good Manufacturing Practices (GMP).
Ø Review Plasma inward, sampling procedures, issuance, and reconciliation activities.
Ø Review and ensure compliance of Downstream Processing and Filling activities as per defined procedures.
Ø Involve in Change Controls, Deviations, CAPA, and other QMS activities.
Ø Participate in Process Validation, Cleaning Validation, and Annual Product Quality Review (APQR) activities.
Ø Participate in Risk Assessment activities in coordination with SMEs.
Ø Perform additional responsibilities assigned by superiors/Head of Department.
Regards,
Vijay-HR
Greetings from Hetero!!
We are excited to announce that we are hiring for the bellow positions for one of our Formulations R&D(OSD) located in Hyderabad.
If you are interested or know someone who might be a good fit, please share the profile with us at Vijayakiran.ch@hetero.com
Open Positions:
- 1) Executive/Senior Executive-FR&D(OSD)
- 2) Assistant Manager/Deputy Manager-FR&D(OSD)
- Qualification:- M.Pharmacy
Key Responsibilities:
Ø Lead the design and development of robust, stable, and bioequivalent oral solid dosage forms (tablets, capsules, etc.), particularly complex generics.
Ø  Plan and execute pre-formulation studies, including reverse engineering of Reference Listed Drugs (RLD), characterization of API and excipients, and assessing drug-excipient compatibility.
Ø  Implement QbD principles and Design of Experiments (DoE) methodologies to achieve a deep understanding of the product and process, define design space, and establish control strategies.
Ø  Conduct thorough literature and patent searches to evaluate the IP landscape, perform freedom-to-operate (FTO) analysis, and devise non-infringement or Paragraph IV strategies for US filings.
Ø  Plan and oversee scale-up activities, including pilot and exhibit batch manufacturing. Facilitate the seamless technology transfer of manufacturing processes from R&D to commercial production sites.
Ø  Identify and resolve formulation and process-related issues encountered during R&D, scale-up, and cGMP manufacturing activities.
Ø  Author and review technical documentation (e.g., Product Development Reports, Master Formula Records, QOS, CMC sections) for regulatory submissions, Prepare effective and comprehensive responses to regulatory queries/deficiencies from various agencies (FDA, EMA, PMDA, etc.).
Ø Work closely with cross-functional teams including Analytical Development, Quality Assurance, Regulatory Affairs, Manufacturing, and Supply Chain to ensure project success and timely milestone achievements.
