Sr. Manager - Quality Assurance

Job Description

JOB DESCRIPTION

• To establish, document and implement Food safety & Quality management system, and to ensure effective implementation, monitoring and control of Food safety & Quality management system at manufacturing, packing, testing and warehouse activities with respect to laid down procedures, systems and identify areas for improvement.
• To review HACCP verification & validation plan, adhere to Schedule-IV of FSSAI for the food premixes division and comply with the requirements of various regulatory authorities and customers.
• To review validation master plan of the plant and comply with the validation requirements of various regulatory authorities and customers.
• To review SOPs, batch manufacturing and packing records, specifications, and test methods of the products.
• To monitor, control and review deviations, change controls, out of specifications may occur at all stages of storage, dispensing, manufacturing, packing, testing and distribution.
• To ensure issuance, control, distribution, storage, retention and destruction of quality documents and corporate guidelines as per Food safety & Quality management system.
• To ensure that all critical equipment and utilities that are used to manufacture the product are under qualified status, calibrated and are under routine preventive maintenance program.
• To ensure proper investigation of market / customer / regulatory complaint by root cause analysis, corrective actions and ensure effective implementation of CAPA initiatives, close the complaints, send responses to the complainants, and verify effectiveness of CAPA periodically.
• To evaluate batch records, COAs and release finished products for sale. To ensure that, all the operations are carried out are as per GMP and laid down procedures, that each production batch complies with the provisions of Food safety & standards (FSS) act and other legal, customer and regulatory requirements.
• To ensure compliance to the regulatory, customer, legal requirements and face audits and comply non-conformities observed during the audits.
• To ensure compliance to the current ISO 9001, D&C Act, FSS Act 2006, FSSC 22000 (including HACCP), FAMI-QS, WHO-GMP and other customer and regulatory requirements.
• To carry out self inspections and ensure compliance to the audit observations of manufacturing, testing, warehousing facility.
• To ensure completion of APRs of products and take appropriate actions in case of deviations.
• Recommendation to recall approving authority on product recall, review, and disposition of recalled and returned goods.
• Handling of online and in process rejections and take appropriate actions to avoid the recurrences and disposition.
• To co-ordinate with CQA for up gradation in the SAP systems as per any changes or new product at Mahad site.
• To monitor stability of products, control sample storage and compilation of analytical reports and take appropriate action in case of failures.
• To identify and provide resources with co-ordination with other departments to carry out quality functions effectively.
• To liaison with regulatory authority for new product permissions, licenses and renewals, certificates, and approvals.
• Ensuring implementation and execution requirements of food regulations for export market (US)-21 CFR Part 110 & 111.
• Ensuring avoidance of breach of data integrity at all the levels.
• Ensuring implementation of effective sanitation activities at all the levels.
• Imparting required training to shop floor personnel.
• Adherence to the requirements of EHS norms.
• To raise the PR for procurement of miscellaneous items, external trainings, certification fees and capex related items.
• To sign the Excess Material Requisition, LRA notes, BMR return notes and other QMS documents in absence of Head- QA.
• To perform MSC2N transactions in SAP.
• Review of Change Control, Deviation, CAPA in trackwise.
• Implementation and execution of various initiatives as are suggested by corporate functions (SEEDS, Learning university, Quality mindset).
• SOP, BMR/BPR, layouts, STP review and approval in ENSUR system.
• To conduct vendor audits for RM/PM.
• To lead and guide the IPQA team for shopfloor activities.
• To set, review and evaluate KRA of reportee’s.
• To share the R&R nominations of team members on quarterly basis.
• To identify and implement the OE projects.
  
  

Qualifications

Qualification: B. Pharm/ M. Pharm/ B.Tech-Food/M.Tech- Food

About Us

In the three decades of its existence, Piramal Group has pursued a twin strategy of both organic and inorganic growth.

Driven by its core values, Piramal Group steadfastly pursues inclusive growth, while adhering to ethical and values-driven practices.

Equal employment opportunity

Piramal Group is proud to be an Equal Employment Opportunity and Affirmative Action employer. We do not discriminate based upon race, ethnicity, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, genetics, or other applicable legally protected characteristics.

We base our employment decisions on merit considering qualifications, skills, performance, and achievements. We endeavor to ensure that all applicants and employees receive equal opportunity in personnel matters, including recruitment, selection, training, placement, promotion, demotion, compensation and benefits, transfers, terminations, and working conditions, including reasonable accommodation for qualified individuals with disabilities as well as individuals with needs related to their religious observance or practice.

About The Team

Piramal Pharma Solutions (PPS) is a Contract Development and Manufacturing Organization (CDMO) offering end-to-end development and manufacturing solutions across the drug life cycle. We serve our customers through a globally integrated network of facilities in North America, Europe, and Asia. This enables us to offer a comprehensive range of services including drug discovery solutions, process & pharmaceutical development services, clinical trial supplies, commercial supply of APIs, and finished dosage forms. We also offer specialized services such as the development and manufacture of highly potent APIs, antibody-drug conjugations, sterile fill/finish, peptide products & services, and potent solid oral drug products. PPS also offers development and manufacturing services for biologics including vaccines, gene therapies, and monoclonal antibodies, made possible through Piramal Pharma Limited’s investment in Yapan Bio Private Limited. Our track record as a trusted service provider with experience across varied technologies makes us a partner of choice for innovators and generic companies worldwide.