Site Quality Head Sterile

Job Summary
We are seeking a qualified candidate to lead the Quality Assurance QC Chemistry and Microbiology Laboratories for the site The role involves developing SOPs ensuring compliance with cGMP and regulatory guidelines and monitoring day-to-day department activities. Responsibilities include proper review and approval of documents execution of in-process controls participation in investigations vendor qualification stability management and ensuring safety practices.

Roles & Responsibilities
You will be responsible for organizing the recruitment and training of QA (Quality Assurance) and laboratory personnel for chemistry and microbiology laboratories.
You will ensure adherence to systems and procedures by all QA and laboratory personnel.
You will be responsible for organizing contract laboratory audits and certification.
You will formulate systems and procedures for the effective implementation of cGMP (Current Good Manufacturing Practices) GLP (Good Laboratory Practices) and other good industry practices as well as various regulations for the manufacture storage and distribution of drug products.
You will be responsible for planning and monitoring the daily activities of different sections of the department and ensure the availability of the required facility and material for carrying out the daily functions.
You will ensure timely review and approval of all Master documents such as Standard Operating Procedures (SOP) Standard Cleaning Procedures Guidelines Operating Instructions Master Production Records Packaging configurations Artworks and other printed packing material specifications Standard procedures Record of Analysis Report General test procedures Cleaning Validation Protocols Stability Protocol Validation Protocol Reports Qualification Protocol Master Validation Plan Master Cleaning Validation and other such reports/documents.
You will be responsible for ensuring proper sampling of all in-process and finished products management of reserve and stability samples and collection of finished products.
You will ensure proper and timely execution of the in-process controls and checks during manufacturing and packing.
Your role includes ensuring proper review and release/rejection of finished drug product batches evaluating and ensuring drug product recall monitoring quantity and final disposition of recalled/returned material.
You will participate in investigations as a site investigation team (SIT) member and ensure proper investigations into Market Complaints to provide suitable CAPA (Corrective and Preventive Actions) to prevent recurrence.
You will be responsible for the timely review approval and implementation of CAPA for all incidents change controls OOS (Out of Specifications) and OOT (Out of Trends).
You will be responsible for timely and accurate vendor qualification proper material management carry vendor and internal audits as required stability management and issuance of field alerts.
As a qualified trainer you will be responsible for implementing training programs ensuring compliance and imparting cGMP and SOP trainings.
You will ensure compliance with the CAPA noted for deficiencies and observations from self-inspections internal audits and external audits.
Your responsibilities include preparation and approval of Annual Product Quality Reviews appraisal of routine activities and issues to higher management involvement in the Adverse Drug Reaction (ADR) Reporting and ensuring departmental adherence to safety practices.
You will also be responsible for safety strength purity and efficacy of the product and any other assignments given by higher management.

Qualifications :

Educational qualification: An M. Pharm/  . with experience in Sterile products

Minimum work experience: 15 to 20 years

Skills & attributes:

Technical Skills
Experience in recruitment and training specifically of QA and laboratory personnel in Chemistry and Microbiology laboratories.
Experience in establishing systems and procedures for cGMP GLP and other industry practices.
Experience in handling investigations self-inspections internal audits and external audits and the ability to approve and implement CAPAs resulting from the investigations.
Skills in vendor qualification vendor audits and material management.

Behavioural Skills
Leadership and organizational skills for effective management of laboratory personnel and operations.
Detail-oriented mind set for thorough review and approval processes.
Strong communication and collaboration skills for internal and external audits investigations and compliance activities.
Commitment to safety practices and adverse drug reaction reporting.

Additional Information :

About the Department
Global Manufacturing Organisation (GMO)
At Dr. Reddys Laboratories we are dedicated to making a meaningful impact on global healthcare through precision manufacturing and innovation. With a legacy of excellence we are a leading force in the pharmaceutical industry.
We operate 19 state-of-the-art manufacturing plants across Hyderabad Vizag Baddi Mexico Shreveport and Mirfield comprising 8 OSD facilities 3 Injectables facilities and 8 API facilities.
Benchmarking manufacturing processes and continuous operational excellence are at the core of our capability to deliver quality medicines to our patients in 66 countries. We manufacture a portfolio of complex APIs and 1150 drug master files across key therapy areas such as Oncology Cardio-vascular Central Nervous System and Anti-Diabetes. he World Economic Forum has recognised our largest manufacturing facility in Bachupally Hyderabad as part of its Global Lighthouse Network. We aspire to be the most efficient pharma operations in the world. Our productivity improvement and digitalisation efforts are key to staying competitive meeting business imperatives and meeting our ambitious ESG goals. Building such factories of the future is integral to innovation and to build healthcare of the future.


Benefits Offered
At Dr. Reddys we actively help to catalyse your career growth and professional development through personalised learning programs.
The benefits you will enjoy at Dr. Reddys are on par with the best industry standards. They include among other things and other essential equipment joining & relocation support family support (Maternity & Paternity benefits) learning and development opportunities medical coverage for yourself and your family life coverage for yourself.

Our Work Culture
Ask any employee at Dr. Reddys why they come to work every day and theyll say because Good Health Cant Wait. This is our credo as well as the guiding principle behind all our actions. We see healthcare solutions not only as scientific formulations but as a means to help patients lead healthier lives and were always attuned to the new and the next to empower people to stay fit. And to do this we foster a culture of empathy and dynamism. People are at the core of our journey over the last few decades. They have been supported by an enabling environment that buoys individual ability while fostering teamwork and shared success. We believe that when people with diverse skills are bound together by a common purpose and value system they can make magic.
For more details please visit our career website at Work :

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